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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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Element System with IBT Electrodes - 00850004850008

Surface electrodes for Electromyography with controller - Coaxial Plug or Ottobock Wrist
INFINITE BIOMEDICAL TECHNOLOGIES, LLC
80101-1
In Commercial Distribution

  • 00850004850008 ()


  • Myoelectric hand prosthesis
  • Analytical non-scalp cutaneous electrode

SleepmateOral/Nasal Cannula with filter - 05707480041848

Oral/Nasal w/filter (50)
Ambu A/S
814320-000/50
In Commercial Distribution

  • 05707480041848 ()
  • 05707480133918 ()
814320-000/50

  • Polysomnograph

Avive AED with Avive Connect - 00860002508559

No Description
Avive Solutions, Inc.
AED01
In Commercial Distribution

  • 00860002508559 ()


  • Rechargeable public automated external defibrillator

Gabriel Feeding Tube with Balloon - 00860000931359

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
12 Fr
In Commercial Distribution

  • 10860000931356 ()
  • 00860000931359 ()

  • Catheter Gauge: 12 French
  • 12 FR (4.2mm)X 52”(130cm)
GFTB 512

  • Nasogastric feeding tube

Gabriel Feeding Tube with Balloon - 00860000931342

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
10 Fr
In Commercial Distribution

  • 10860000931349 ()
  • 00860000931342 ()

  • 10 Fr (3.7mm)X 49”(100cm)
  • Catheter Gauge: 10 French
GFTB 510

  • Nasogastric feeding tube

Gabriel Feeding Tube with Balloon - 00860000931335

and EnFit Connector
SYNCRO MEDICAL INNOVATIONS
8 Fr
In Commercial Distribution

  • 10860000931332 ()
  • 00860000931335 ()

  • Catheter Gauge: 8 French
  • 8 FR (3.3mm)X 32”(80cm)
GFTB 508

  • Nasogastric feeding tube

Mobile Touch Dock with battery - 05704916001087

Mobile Touch Dock with battery. Includes Power Cable Holder
Bk Medical ApS
UA1814
Not in Commercial Distribution

  • 05704916001087 ()


  • General-purpose ultrasound imaging system

Mobile Keyboard Dock with battery - 05704916001056

Mobile Keyboard Dock with backpack and battery. Includes Power Cable Holder
Bk Medical ApS
UA1214
Not in Commercial Distribution

  • 05704916001056 ()


  • General-purpose ultrasound imaging system

OSMETTE III with Barcode Reader - 00850041049830

Precision Systems OSMETTE III osmometer with Barcode Reader
Precision Systems, Inc.
5010B
In Commercial Distribution

  • 00850041049830 ()
5010B

  • Osmometric analyser IVD

OSMETTE XL with Barcode Reader - 00850041049762

Precision Systems OSMETTE XL with Barcode Reader
Precision Systems, Inc.
5007B
In Commercial Distribution

  • 00850041049762 ()
5007B

  • Osmometric analyser IVD
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