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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

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DL950 Braemar Base - B146DL95020

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-02
In Commercial Distribution

  • B146DL95020 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar - B146DL95010

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-01
In Commercial Distribution

  • B146DL95010 ()


  • Electrocardiographic ambulatory recorder

DL950 Braemar - B146DL95000

No Description
BRAEMAR MANUFACTURING, LLC
900-0616-00
In Commercial Distribution

  • B146DL95000 ()


  • Electrocardiographic ambulatory recorder

DL900 - B146DL9280

No Description
BRAEMAR MANUFACTURING, LLC
900-0570-28
In Commercial Distribution

  • B146DL9280 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav Encrypted - B146DL8NVE0

DL800 Holter recorder
BRAEMAR MANUFACTURING, LLC
900-0543-21
In Commercial Distribution

  • B146DL8NVE0 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav - B146DL8NV0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-20
In Commercial Distribution

  • B146DL8NV0 ()


  • Electrocardiographic ambulatory recorder

DL800 Norav 256 s/s 8bit - B146DL8NO2560

Holter Monitor
BRAEMAR MANUFACTURING, LLC
900-0543-12
In Commercial Distribution

  • B146DL8NO2560 ()


  • Electrocardiographic ambulatory recorder

DL800 Forest Medical 256 s/s 8 bit - B146DL8FM0

Holter Recorder
BRAEMAR MANUFACTURING, LLC
900-0543-17
In Commercial Distribution

  • B146DL8FM0 ()


  • Electrocardiographic ambulatory recorder

DL800 CardioNet - B146DL8CN0

Holter Monitor
BRAEMAR MANUFACTURING, LLC
900-0543-15
In Commercial Distribution

  • B146DL8CN0 ()


  • Electrocardiographic ambulatory recorder

C6 Monitor A13, Verizon - B146C6M90

No Description
BRAEMAR MANUFACTURING, LLC
02-02118
In Commercial Distribution

  • B146C6M90 ()


  • Electrocardiographic ambulatory recorder

BTP-1000L-2 BTI - B146BTPL210

No Description
BRAEMAR MANUFACTURING, LLC
02-01560
In Commercial Distribution

  • B146BTPL210 ()


  • Electrocardiographic ambulatory recorder

LessRay - 00887517992789

LessRay Keyboard, iKey
Nuvasive, Inc.
1675899
In Commercial Distribution

  • 00887517992789 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517976062

LessRay Extension, Table Array
Nuvasive, Inc.
8230042
In Commercial Distribution

  • 00887517976062 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517996022

LessRay CE Table Array Set
Nuvasive, Inc.
LRTABLELOANCE
In Commercial Distribution

  • 00887517996022 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517994813

Lessray Touchscreen Monitor
Nuvasive, Inc.
8230044
In Commercial Distribution

  • 00887517994813 ()


  • Diagnostic x-ray digital imaging system workstation

LessRay - 00887517994806

Lessray PAL to NTSC Converter Assembly
Nuvasive, Inc.
8230043
In Commercial Distribution

  • 00887517994806 ()


  • Diagnostic x-ray digital imaging system workstation

Caring Mill - 00810025928476

Caring Mill Light Therapy Cleansing Brush
LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED
CM-HD-05-I
In Commercial Distribution

  • 00810025928476 ()


  • Red/blue light phototherapy unit

Me - 00806248007562

Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region
Tanda Beauty Canada, Inc
Series 15
In Commercial Distribution

  • 00806248007562 ()
  • 00806248006770 ()
  • 10806248007569 ()
  • 20806248007566 ()
HU-FG01881

  • Red/blue light phototherapy unit

Me - 00806248007555

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Tanda Beauty Canada, Inc
Series 14
In Commercial Distribution

  • 20806248007559 ()
  • 10806248007552 ()
  • 00806248007555 ()
HU-FG01871

  • Red/blue light phototherapy unit

Me - 00806248007463

Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a store display.
Tanda Beauty Canada, Inc
Series 15
In Commercial Distribution

  • 00806248007463 ()
  • 00806248006770 ()
HU-CO00901

  • Red/blue light phototherapy unit

Me - 00806248007432

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne. This is a store display.
Tanda Beauty Canada, Inc
Series 14
In Commercial Distribution

  • 00806248007432 ()
HU-CO00871

  • Red/blue light phototherapy unit

Me - 00806248007425

Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a tester device.
Tanda Beauty Canada, Inc
Series 15
In Commercial Distribution

  • 00806248007425 ()
HU-FG01821

  • Red/blue light phototherapy unit

Me - 00806248007289

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne. This is a store display. One device count includes 1 tester and 6 units.
Tanda Beauty Canada, Inc
Series 14
In Commercial Distribution

  • 00806248007289 ()
HU-CO00821

  • Red/blue light phototherapy unit

Me - 00806248007241

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne. This is a tester device.
Tanda Beauty Canada, Inc
Series 14
In Commercial Distribution

  • 00806248007241 ()
HU-FG01721

  • Red/blue light phototherapy unit

Me - 00806248006459

Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region
Tanda Beauty Canada, Inc
Series 15
In Commercial Distribution

  • 00806248006459 ()
  • 00806248006770 ()
  • 10806248006456 ()
  • 20806248006453 ()
HU-FG01281

  • Red/blue light phototherapy unit

Me - 00806248006114

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Tanda Beauty Canada, Inc
Series 14
In Commercial Distribution

  • 20806248006118 ()
  • 10806248006111 ()
  • 00806248006114 ()
HU-FG01271

  • Red/blue light phototherapy unit

Tanda - 00806248005186

Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Tanda Beauty Canada, Inc
Series 4
In Commercial Distribution

  • 20806248005180 ()
  • 10806248005183 ()
  • 00806248005186 ()
HU-FG00961

  • Red/blue light phototherapy unit

Tanda - 00806248004936

Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Tanda Beauty Canada, Inc
Series 4
In Commercial Distribution

  • 20806248004930 ()
  • 10806248004933 ()
  • 00806248004936 ()
HU-FG00631

  • Red/blue light phototherapy unit

Tanda - 00806248004929

Home use, hand held, blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Tanda Beauty Canada, Inc
Series 4
In Commercial Distribution

  • 00806248004929 ()
  • 10806248004926 ()
  • 20806248004923 ()
HU-FG00621

  • Red/blue light phototherapy unit

Pdt-Face - 06970453270005

No Description
Beijing ADSS Development Co., Ltd.
PDT-FACE
In Commercial Distribution

  • 06970453270005 ()


  • Red/blue light phototherapy unit

THD Anopress - 18033737711412

THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software.
THD SPA
THD Anopress
In Commercial Distribution

  • 18033737711412 ()
800160

  • Manometric gastrointestinal motility analysis system

THD Anopress - 18033737711245

THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software.
THD SPA
THD Anopress
In Commercial Distribution

  • 18033737711245 ()
800140

  • Manometric gastrointestinal motility analysis system

Digistat Smart Central - 17350097870032

Digistat Smart Central is an on-site integration solution which forwards medical device status and alarm information to the user via display devices provided by Ascom or third-party companies. Users receive, time-critical information from connected medical devices directly via their display devices as text, alarms or data. Digistat Smart Central allows users to be aware of their patients’ status and alarm conditions when they are away from the patient and associated medical devices.
ASCOM UMS SRL
SW000754
In Commercial Distribution

  • 17350097870032 ()


  • Alarm application software

Ascom - 17350088671273

No Description
Ascom (Sweden) AB
Unite Connect for Clinical Systems
In Commercial Distribution

  • 17350088671273 ()
SW000466

  • Alarm application software

Ascom - 17350088670016

No Description
Ascom (Sweden) AB
Cardiomax
In Commercial Distribution

  • 17350088670016 ()
SW000466

  • Alarm application software

Ascom - 17350088670009

No Description
Ascom (Sweden) AB
Mobile Monitoring Gateway (MMG)
In Commercial Distribution

  • 17350088670009 ()
SW000400

  • Alarm application software

Microlife - 06970388169528

No Description
MICROLIFE USA, INC.
Cuff-LXL-WBPA
In Commercial Distribution

  • 16970388169525 ()
  • 06970388169528 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169511

WatchBP O3 L size Nylon cuff
MICROLIFE USA, INC.
Cuff-L-WBPA
In Commercial Distribution

  • 16970388169518 ()
  • 06970388169511 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169504

No Description
MICROLIFE USA, INC.
Cuff-M-WBPA
In Commercial Distribution

  • 16970388169501 ()
  • 06970388169504 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169498

No Description
MICROLIFE USA, INC.
CUFF-S-WBPA
In Commercial Distribution

  • 16970388169495 ()
  • 06970388169498 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169467

No Description
MICROLIFE USA, INC.
CUFF-LXL-WBPO
In Commercial Distribution

  • 16970388169464 ()
  • 06970388169467 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169450

No Description
MICROLIFE USA, INC.
Cuff-L-WBPO
In Commercial Distribution

  • 16970388169457 ()
  • 06970388169450 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169443

No Description
MICROLIFE USA, INC.
Cuff-M-WBPO
In Commercial Distribution

  • 16970388169440 ()
  • 06970388169443 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169436

No Description
MICROLIFE USA, INC.
CUFF-S-WBPO
In Commercial Distribution

  • 16970388169433 ()
  • 06970388169436 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169429

No Description
MICROLIFE USA, INC.
Cuff-L-WBPH
In Commercial Distribution

  • 16970388169426 ()
  • 06970388169429 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169290

No Description
MICROLIFE USA, INC.
Cuff-S-WBPH
In Commercial Distribution

  • 16970388169297 ()
  • 06970388169290 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169221

No Description
MICROLIFE USA, INC.
Cuff-LXL-WBPH
In Commercial Distribution

  • 16970388169228 ()
  • 06970388169221 ()


  • Arrythmia-detection sphygmomanometer

Microlife - 06970388169191

No Description
MICROLIFE USA, INC.
CUFF-M-WBPH
In Commercial Distribution

  • 16970388169198 ()
  • 06970388169191 ()


  • Arrythmia-detection blood pressure ambulatory recorder

Microlife - 06970388169160

No Description
MICROLIFE USA, INC.
BP3MX1-3
In Commercial Distribution

  • 16970388169167 ()
  • 06970388169160 ()
  • 26970388169164 ()


  • Arrythmia-detection sphygmomanometer

LessRay - 00887517764133

LessRay IR Camera and Clamp
Nuvasive, Inc.
8230020
In Commercial Distribution

  • 00887517764133 ()


  • Diagnostic x-ray digital imaging system workstation
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