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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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USB 2.0 Cable (WireFree) - 00853818007187

6 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-200
In Commercial Distribution

  • 00853818007187 ()


  • Medical device USB cable

SCHICK ELITE - D764B22501521

USB REMOTE HS / ELITE CABLE (0.5 METER)
SIRONA DENTAL, INC.
B2250152
In Commercial Distribution

  • D764B22501521 ()


  • Medical device USB cable

SCHICK ELITE - D764B22501501

USB REMOTE HS / ELITE CABLE (5 METER)
SIRONA DENTAL, INC.
B2250150
In Commercial Distribution

  • D764B22501501 ()


  • Medical device USB cable

SCHICK ELITE - D76464042351

USB REMOTE HS / ELITE CABLE (2 METER)
SIRONA DENTAL, INC.
6404235
In Commercial Distribution

  • D76464042351 ()


  • Medical device USB cable

XIOS - D76461443511

USB A/B 3M BLACK CABLE W/FERRITE
SIRONA DENTAL, INC.
6144351
In Commercial Distribution

  • D76461443511 ()


  • Medical device USB cable

BRAEBON Communication Cable for MediByte - B1408889210

Cable for connecting the MediByte to the computer for configuration and data download.
Braebon Medical Corporation
8889.21
In Commercial Distribution

  • B1408889210 ()
8889.21

  • Medical device USB cable

Patient Gateway - 05060488680311

SM-X205 - 10.5 Screen - GSM Data entry & local display point tablet computer, 10.5 Screen
ISANSYS LIFECARE LIMITED
SM-X205 - 10.5 Screen - GSM
In Commercial Distribution

  • 05060488680311 ()
Gateway SM-X205 GSM

  • Physiological measuring device wireless data capture/transfer unit

Remote Network Station - 00851725007276

Remote Network Station with Dell OptiPlex 7490 23.8” All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7490-U
In Commercial Distribution

  • 00851725007276 ()
RNS-6803-7490-U

  • Centralized patient monitor

Remote Network Station - 00851725007252

Remote Network Station with Dell OptiPlex 7480 23.8” All-In-One Computer SW 02-18 unicast
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7480-U
In Commercial Distribution

  • 00851725007252 ()
RNS-6803-7480-U

  • Centralized patient monitor

Neuroband - 00850010086033

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30SB
Not in Commercial Distribution

  • 00850010086033 ()


  • Psychophysiological biofeedback system
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