Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

Show Filters

504W/ATT Nat Rubber 40-50mmHg U L3 Right Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006891 ()

  • Pressure,40-50 mmHg
504WL3O77/R or 80916

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U L3 Left Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006884 ()

  • Pressure,40-50 mmHg
504WL3O77/L or 80910

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U M4 Right Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006877 ()

  • Pressure,40-50 mmHg
504WM4O77/R or 80915

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U M4 Left Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006860 ()

  • Pressure,40-50 mmHg
504WM4O77/L or 80909

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U M3 Right Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006853 ()

  • Pressure,40-50 mmHg
504WM3O77/R or 80914

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U M3 Left Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006846 ()

  • Pressure,40-50 mmHg
504WM3O77/L or 80908

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U S4 Right Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006839 ()

  • Pressure,40-50 mmHg
504WS4O77/R or 80913

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U S4 Left Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006822 ()

  • Pressure,40-50 mmHg
504WS4O77/L or 80907

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U S3 Right Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006815 ()

  • Pressure,40-50 mmHg
504WS3O77/R or 80912

  • Compression/pressure sock/stocking, single-use
504W/ATT Nat Rubber 40-50mmHg U S3 Left Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504W
In Commercial Distribution

  • 00745129006808 ()

  • Pressure,40-50 mmHg
504WS3O77/L or 80906

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U L4 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006792 ()

  • Pressure,40-50 mmHg
504TL4O77 or 21251

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U M4 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006785 ()

  • Pressure,40-50 mmHg
504TM4O77 or 21252

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U S4 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006778 ()

  • Pressure,40-50 mmHg
504TS4O77 or 21253

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U L2 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006761 ()

  • Pressure,40-50 mmHg
504TL2O77 or 21248

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U M2 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006754 ()

  • Pressure,40-50 mmHg
504TM2O77 or 21249

  • Compression/pressure sock/stocking, single-use
504N No Grp Nat Rubber 40-50mmHg U S2 Beige. A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
504T
In Commercial Distribution

  • 00745129006747 ()

  • Pressure,40-50 mmHg
504TS2O77 or 21250

  • Compression/pressure sock/stocking, single-use
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940763 ()


  • Self-care monitoring/reporting software
The Samsung ECG Monitor Application with Irregular Heart Rhythm Notification is an over-the-counter (OTC) software-only, mobile medical application operating on a compatible Samsung Galaxy Watch and Phone for informational use only in adults 22 years and older. The app analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification suggesting the user record an ECG to analyze the heart rhythm. The Irregular Heart Rhythm Notification Feature is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically acquire pulse rate data when the user is still and analyze the data when determined sufficient toward surfacing a notification.
Samsung Electronics Co., Ltd.
1.X
In Commercial Distribution

  • 08806094940756 ()


  • Self-care monitoring/reporting software
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or forhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301830# hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188863 ()

  • Pressure,30-40 mmHg
923CSSM99

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fithttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301826#ted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188849 ()

  • Pressure,30-40 mmHg
923CMSM99

  • Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301808#
SIGVARIS INC
923C
In Commercial Distribution

  • 00745129188832 ()

  • Pressure,30-40 mmHg
923CLLM99

  • Compression/pressure sock/stocking, single-use
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias. The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution

  • 00810038851983 ()


  • Cardiopulmonary physiological parameter analysis software
50 Person Large Plastic SmartCompliance First Aid Cabinet With OTC Medications - Contains: Adhesive Fabric Bandages, 1" x 3", 25 ct; Adhesive Plastic Bandages, 0.75" x 3", 25 ct; Alcohol Pads, 20 ct; Antibiotic Ointment Packets, 10 ct; Antiseptic Wipes, 20 ct; Aspirin Tablets, 20 ct; Burn Dressing, 4" x 4"; Cold Pack, 4" x 5"; CPR Face Shield and 2 Nitrile Exam Gloves; Extra Strength Non-Aspirin Tablets, 20 ct; Fingertip Fabric Bandages, 10 ct; First Aid Guide; First Aid Tape, 0.5" x 5 yd and Gauze Roll, 2" x 4 yd; First Aid/Burn Cream Packets, 10 ct; Hand Sanitizer Packets, 10 ct; Ibuprofen Tablets, 20 ct; Nitrile Exam Gloves, 4 ct; Patch Plastic Bandages, 1.5" x 1.5”, 10 ct: Scissors; Sterile Eye pads 2 ct, 1 oz Eyewash, and 0.5" x 5 yd Tape Roll; Sterile Gauze Pads, 2" x 2", 10 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Trauma Pads, 5" x 9", 2 ct; Triangular Bandage, 40" x 40" x 56"; Tweezers.
Acme United Corporation
90608
In Commercial Distribution

  • 00092265906081 ()
90608

  • First aid kit, medicated
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-31-5
In Commercial Distribution

  • 56971227400395 ()
  • 36971227400391 ()
  • 16971227400380 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-5
In Commercial Distribution

  • 36971227400384 ()
  • 16971227400380 ()
  • 56971227400388 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. The products has several models. Different models are distinguished by needle gauge and length. The Safety Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The product is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
SPN-30-8
In Commercial Distribution

  • 56971227400371 ()
  • 36971227400377 ()
  • 16971227400373 ()


  • Autoinjector needle
The Fitbit Irregular Rhythm Notifications is a software-only mobile medical application that is intended to be used with compatible consumer wrist-worn products to analyze pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provide a notification to the user. The Fitbit Irregular Rhythm Notifications is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the Fitbit Irregular Rhythm Notifications is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the Fitbit Irregular Rhythm Notifications can be used to supplement the decision for AFib screening. The Fitbit Irregular Rhythm Notifications is not intended to replace traditional methods of diagnosis or treatment. The Fitbit Irregular Rhythm Notifications has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.
FITBIT, INC.
FB604
In Commercial Distribution

  • 00810038852720 ()
FB604

  • Cardiopulmonary physiological parameter analysis software
3 Shelf First Aid Kit Refill with OTC Medications - Contains: Adhesive Fabric Bandages, 1" x 3", 100 ct; Adhesive Fabric Bandages, 2" x 4", 6 ct; Alcohol Wipes, 100 ct; Antacid Tablets, 100 ct; Antiseptic Spray, 4 oz; Burn Dressing, 4" x 4"; Burn Spray, 4 oz; Cold Pack, 6" x 9", 2 ct; Conforming Gauze Rolls, 2", 2 ct; Cotton Tipped Applicators, 100 ct; CPR Face Shield; Elastic Bandage Wrap, 4" x 5 yd; Extra-Strength Non-Aspirin, 100 ct; Eyewash, 4 oz bottle; Fingertip and Knuckle Fabric Bandages, 50 ct; First Aid Guide; First Aid/Burn Cream Packets, 25 ct; Hand Sanitizer Packets, 10 ct; Hema-Flex 5 x 9 Trauma Pad in 4” x 4 yd gauze, : Nitrile Exam Gloves, 12 ct; Padded Flexible Splint, 4.25" x 24"; Scissors; Sterile Eye Pads and Strips, 4 ct; Sterile Gauze Pads, 3" x 3", 10 ct; Sterile Gauze Pads, 4" x 4", 10 ct; Sterile Stretch Compress Bandage, 4"; Stretch Tourniquet, 1" x 18"; Trauma Pad, 5" x 9", 3 ct; Triangular Bandage, 40" x 40" x 56", 2 ct; Triple Antibiotic Ointment Packets, 25 ct; Triple Cut Adhesive Tape Roll, 2"; Tweezer
Acme United Corporation
90623
In Commercial Distribution

  • 00092265906234 ()
90623

  • First aid kit, medicated
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safe Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-4
In Commercial Distribution

  • 36971227400025 ()
  • 56971227400029 ()
  • 16971227400021 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safe Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-30-8
In Commercial Distribution

  • 36971227400018 ()
  • 56971227400012 ()
  • 16971227400014 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-29-12
In Commercial Distribution

  • 36971227400001 ()
  • 56971227400005 ()
  • 16971227400007 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-33-4
In Commercial Distribution

  • 36971227400766 ()
  • 16971227400762 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-8
In Commercial Distribution

  • 36971227400759 ()
  • 16971227400755 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-5
In Commercial Distribution

  • 36971227400742 ()
  • 16971227400748 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-32-4
In Commercial Distribution

  • 36971227400735 ()
  • 16971227400731 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-8
In Commercial Distribution

  • 36971227400728 ()
  • 16971227400724 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-6
In Commercial Distribution

  • 36971227400711 ()
  • 16971227400717 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safe Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-5
In Commercial Distribution

  • 36971227400704 ()
  • 16971227400700 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safe Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-31-4
In Commercial Distribution

  • 36971227400698 ()
  • 16971227400694 ()


  • Autoinjector needle
The products have two types, common type and safety type. Both of the two types are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. Each type has several models. Different models are distinguished by needle gauge and length. The Common Type Insulin Pen Needle consists of needle container, needle shield, needle tube, needle hub, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The Safety Type Insulin Pen Needle consists of needle tube, needle shield, spring, housing, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Safe Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Both the Common Type Insulin Pen Needle and the Safety Type Pen Needle are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
IPN-30-8
In Commercial Distribution

  • 36971227400681 ()
  • 16971227400687 ()


  • Autoinjector needle
< 1 ... 204 205 206 207 208 209 >