SEARCH RESULTS FOR: 葵湧OTC网：(www.hkotc.cc)4t7x(8341 results)
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 2
In Commercial Distribution
- 10857538000043 ()
- 00857538000022 ()
- 10857538000272 ()
- 10857538000081 ()
DV002
- Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model 1
In Commercial Distribution
- 10857538000258 ()
- 00857538000015 ()
- 10857538000074 ()
- 10857538000036 ()
DV001
- Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model Teen Size
Not in Commercial Distribution
- 00857538000244 ()
DV00T
- Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
MT Cup Model B
Not in Commercial Distribution
- 00857538000169 ()
MT002
- Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
DOT INTERNATIONAL L3C
1
In Commercial Distribution
- 00860499001908 ()
- Menstrual cup, non-latex, reusable
A convenient collection of equipment and materials typically used in an emergency by a layperson to repair a damaged denture. It is available [non-prescription] over-the-counter (OTC) and enables the permanent repair of denture cracks and breaks without professional assistance. It typically consists of dental adhesive materials (e.g., a resin monomer system of powder and liquid glue) and mixing and application utensils. After application, this device cannot be reused.
PERMA LABORATORIES LLC
pk6
In Commercial Distribution
- 00852305002117 ()
- Denture repair kit, home-use
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model B PL
In Commercial Distribution
- 00050428645888 ()
634864
- Menstrual cup, non-latex, reusable
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons.It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
Diva International Inc
Model A PL
In Commercial Distribution
- 00050428645598 ()
722537
- Menstrual cup, non-latex, reusable
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has
several models. Different models are distinguished by needle gauge and length.
The Blood Lancet consists of needle tube and needle hub.
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.
11G-2091-K
In Commercial Distribution
- 86971227402543 ()
- 06971227402547 ()
- Autoinjector needle
The products are sterile with a
Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has
several models. Different models are distinguished by needle gauge and length.
The Blood Lancet consists of needle tube and needle hub.
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.
11G-2090-J
In Commercial Distribution
- 06971227402530 ()
- 86971227402536 ()
- Autoinjector needle
Reusable Menstrual Cup Menstrual Cup Model B.
Medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
WALGREEN CO.
864133
In Commercial Distribution
- 00311917057446 ()
- 10311917057443 ()
- Menstrual cup, non-latex, reusable
Reusable Menstrual Cup, Model A.
Menstrual Cup, medical grade silicone, non-latex, soft reusable bell shape cup placed by the user into the vagina, held in place by suction and used to collect menstrual flow during menstruation in lieu of absorbent pads or tampons. It is available OTC (Over the counter). It is removed from the vagina by releasing the suction and pulling on the protruding stem. This is a reusable device for a single user.
WALGREEN CO.
864224
In Commercial Distribution
- 00311917057415 ()
- 10311917057412 ()
- Menstrual cup, non-latex, reusable
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7103106-100
In Commercial Distribution
- 10850011833831 ()
- 00850011833834 ()
- 80850011833830 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033106-100
In Commercial Distribution
- 10850011833824 ()
- 00850011833827 ()
- 80850011833823 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8103108-100
In Commercial Distribution
- 10850011833794 ()
- 00850011833797 ()
- 80850011833793 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8102912-100
In Commercial Distribution
- 10850011833787 ()
- 00850011833780 ()
- 80850011833786 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8053108-100
In Commercial Distribution
- 10850011833770 ()
- 00850011833773 ()
- 80850011833779 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8052912-100
In Commercial Distribution
- 10850011833763 ()
- 00850011833766 ()
- 80850011833762 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-8033108-100
In Commercial Distribution
- 10850011833756 ()
- 00850011833759 ()
- 80850011833755 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution
- 10850011833565 ()
- 00850011833568 ()
- 80850011833564 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution
- 10850011833558 ()
- 00850011833551 ()
- 80850011833557 ()
- Insulin syringe/needle, basic
Catasyn OTC is indicated for the dressing and management of minor burns, minor cuts, minor lacerations, minor abrasions, and minor irritations of the skin.
Catasyn may be used under the direction of a health care professional for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (postoperative incisions and donor sites) and superficial and partial thickness (second degree) burns.
SYNEDGEN, INC.
3 oz
In Commercial Distribution
- 00852181005332 ()
- Total Volume: 3 Fluid Ounce
- Wound hydrogel dressing, non-antimicrobial
Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control.
ARKRAY USA, INC.
502030
In Commercial Distribution
- 00015482502300 ()
- 50015482502305 ()
- 10015482502307 ()
N/A
- Glucose monitoring system IVD, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
4c
In Commercial Distribution
- 00852305002070 ()
- Denture reliner, soft, home-use
A device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture for improved fitting. It is available [non-prescription] over-the-counter (OTC) and will enable the user to make a permanent adjustment without professional assistance. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). After application, this device cannot be reused.
PERMA LABORATORIES LLC
2ps
In Commercial Distribution
- 00852305002018 ()
- Denture reliner, soft, home-use
Refill For SmartCompliance Cabinet With OTC Medications - Contains: Alcohol Pad, 20 ct; Antibiotic Ointment, 10 ct; Antiseptic Wipes, 10 ct; Aspirin Tablets, 20 ct; Butterfly Wound Closure, 10 ct; Extra-Strength Non-Aspirin Tablets, 20 ct; Fabric Bandage, 1" x 3", 50 ct; Fingertip Fabric Bandage, 10 ct; First Aid Tape, 1/2" x 10 yd; First Aid/Burn Cream, 10 ct; Gauze Roll Bandage, 3”; Ibuprofen Tablets, 40 ct; Knuckle Fabric Bandage, 10 ct; Plastic Bandage, 3/4" x 3", 25 ct.
Acme United Corporation
700002
In Commercial Distribution
- 00092265700023 ()
700002
- First aid kit, medicated
ONE-CARE test strips are intended for use with ONE-CARE glucose meters for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). ONE-CARE system can be used at home (over the counter OTC) by persons with diabetes. Test strips require small blood samples size of 0.5ul to provide accurate and fast results within 5 seconds. The system is based on auto-coding technology and no programming is needed when using new batch of test strips.
MediVena, LLC
AC500
In Commercial Distribution
- 00810008210512 ()
- 00810008210369 ()
- 00810008210529 ()
4007
- Glucose monitoring system IVD, home-use
A cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by pulling on a protruding stem; depending upon design, it may or may not touch the cervix. The device can function as an alternative to tampons. This is a reusable device.
MIEUX LLC
1
Not in Commercial Distribution
- 00868609000216 ()
- Menstrual cup, non-latex, reusable
The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.
Nira Innovations Incorporated
104-000
Not in Commercial Distribution
- 00860296000142 ()
- Dermatological laser beam guiding handpiece
The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips or forearm. The EASY MAX Glucose Test Strips must be used with the EASY MAX Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.
EPS BIO TECHNOLOGY CORP.
EASY MAX
In Commercial Distribution
- 10885017000277 ()
- 00885017000270 ()
- Glucose IVD, kit, enzyme spectrophotometry, rapid
YE8800CR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800CR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
YE8800CR
In Commercial Distribution
- 06933257921610 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
YE8800AR is a rechargeable lithium battery-powered, automatic, noninvasive, wrist-worn blood pressure measuring system intended for over-the-counter (OTC) use. YE8800AR is designed for wrist circumference ranging from 13.5 cm to 19.5 cm. The systolic and diastolic blood pressures are measured using the oscillometric method, where the cuff is inflated with an air pump and deflates via an exhaust valve. During inflation, the cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then further analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure.
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
YE8800AR
In Commercial Distribution
- 06933257921634 ()
- Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Dream Sock Software App.
The Dream Sock is intended for over-the-counter (OTC) use only in a home environment. It is not
intended to provide notification for every episode of the unexpected occurrences of elevated or
depressed PR or a low SpO2 level; rather, the Dream Sock is intended to provide a notification only
when sufficient data are available for analysis. The notifications and associated data can be used to
supplement the decision by caregivers to seek additional guidance for medical care of the infant. The
Dream Sock is not intended to replace traditional methods of monitoring, diagnosis or treatment.
Owlet Baby Care, Inc.
3.0
In Commercial Distribution
- 00810099090819 ()
- Multiple vital physiological parameter monitoring system, home-use
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
Doc Brands, Inc.
1
In Commercial Distribution
- 00372494101960 ()
- Denture reliner, soft, home-use
VOXAPOD menstrual cup small is a uniquely designed device that collects menstrual flow rather than absorbing it. It is a cup-like receptacle placed by the user into the vagina to collect blood and cellular debris discharges during menstruation and discharges outside of the monthly menses. It is a small, soft device made of a biocompatible synthetic material (e.g., silicone elastomer) and is normally available [non-prescription] over-the-counter (OTC). It is typically removed from the vagina by breaking the suction seal and pulling on the stem and/or base. The device can function as an alternative to tampons. This is a reusable device.
Voxa Pod, Inc.
VP-Cup-Sm-C
In Commercial Distribution
- 00860000762335 ()
- Menstrual cup, non-latex, reusable
REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
Revian, Inc.
101
In Commercial Distribution
- 00862712000309 ()
- Width: 20 Centimeter
- Weight: 155 Gram
- Length: 22.86 Centimeter
- Height: 15.87 Centimeter
10001
- Hair growth laser device
The device is a temporary OTC soft, clear denture reliner consisting of 2 parts (1) a monomer liquid and (2) a polymer powder which are mixed together prior to application. This results in a plastic resin paste which is then applied to the denture plate and set in the mouth to cure for a short period of time. Once setting is complete, the excess soft material is able to be trimmed by an enclosed spatula. The application is completely reversible by soaking the denture plate overnight in an over the counter solution of hydrogen peroxide and then removing it by hand.
MAJESTIC DRUG CO. INC.
1
In Commercial Distribution
- 00010705400968 ()
- 50010705400963 ()
- 30010705400969 ()
- 40010705400966 ()
- 20010705400962 ()
- Denture reliner, soft, home-use
The products 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 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.
IPN-32-4
In Commercial Distribution
- 16975965297714 ()
- 06975965297717 ()
- 86975965295269 ()
- Autoinjector needle
The products 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 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.
IPN-32-6
In Commercial Distribution
- 16975965297257 ()
- 06975965297250 ()
- 86975965297256 ()
- Autoinjector needle
The products 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 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.
IPN-32-4
In Commercial Distribution
- 16975965297240 ()
- 06975965297243 ()
- 86975965297249 ()
- Autoinjector needle