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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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TeleSense/Chroma2 Download Cable - 00856298006152

USB cable designed to connect with TeleSenseRCM, TeleSense-E, and Chroma2 devices to download device data.
SCOTTCARE CORPORATION, THE
TeleSense/Chroma2 Download Cable
In Commercial Distribution

  • 00856298006152 ()
101825

  • Medical device USB cable

Nonin - 00849686072235

USB Adapted, Serial Converter
NONIN MEDICAL, INC.
1000USB
In Commercial Distribution

  • 00833166009293 ()
  • 00849686072235 ()
  • 00833166004755 ()


  • Medical device USB cable

Nonin - 00849686072228

USB Cable
NONIN MEDICAL, INC.
1000USB-C
In Commercial Distribution

  • 00833166004052 ()
  • 00849686072228 ()


  • Medical device USB cable

USB 2.0 Cable (WireFree) - 00853818007323

3 ft. USB 2.0 cable for connecting a PhysioMonitor, SoloVision or VisionPort to a computer
PRECISION BIOMETRICS INC
PB-202
In Commercial Distribution

  • 00853818007323 ()
PB-202

  • Medical device USB cable

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

Neuroband - 00850010086026

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
GFM30MD
Not in Commercial Distribution

  • 00850010086026 ()


  • Psychophysiological biofeedback system

Dreem 2 - 00850010086019

Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system

PARO Robot - 04580537541246

A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Pink
In Commercial Distribution

  • 04580537541246 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541239

A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Charcoal Gray
In Commercial Distribution

  • 04580537541239 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541222

A baby seal type robot with artificial intelligence in Gold Color Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Gold
In Commercial Distribution

  • 04580537541222 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541215

A baby seal type robot with artificial intelligence Neurological Therapeutic Medical Device Biofeedback Medical Device For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC White
In Commercial Distribution

  • 04580537541215 ()
V9-14UC

  • Psychophysiological biofeedback system

Trigno Avanti Sensor, 4-Pack - 00851679007407

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007407 ()


  • Psychophysiological biofeedback system

Trigno Wireless Biofeedback System - 00851679007391

Biofeedback Device
DELSYS, INC.
DS-T04
In Commercial Distribution

  • 00851679007391 ()


  • Psychophysiological biofeedback system

Trigno Charge-16 - 00851679007384

Biofeedback Device.
DELSYS, INC.
SP-W09
In Commercial Distribution

  • 00851679007384 ()


  • Psychophysiological biofeedback system

Trigno Centro - 00851679007377

Biofeedback Device.
DELSYS, INC.
SP-W10
In Commercial Distribution

  • 00851679007377 ()


  • Psychophysiological biofeedback system

Trigno Avanti Sensor - 00851679007360

Biofeedback Device
DELSYS, INC.
SP-W11
In Commercial Distribution

  • 00851679007360 ()


  • Psychophysiological biofeedback system

Trigno Maize Sensor - 00851679007353

Trigno Wireless Biofeedback System component.
DELSYS, INC.
SP-W06-029
In Commercial Distribution

  • 00851679007353 ()


  • Psychophysiological biofeedback system

Trigno Avanti Duo Sensor - 00851679007346

Trigno System Component
DELSYS, INC.
SP-W06-027
In Commercial Distribution

  • 00851679007346 ()


  • Psychophysiological biofeedback system

Trigno Avanti EKG Biofeedback Sensor - 00851679007339

Trigno System Component
DELSYS, INC.
SP-W06-021
In Commercial Distribution

  • 00851679007339 ()


  • Psychophysiological biofeedback system

Trigno Avanti Load Cell Adapter - 00851679007322

Trigno System Component
DELSYS, INC.
SP-W06-022
In Commercial Distribution

  • 00851679007322 ()


  • Psychophysiological biofeedback system

Trigno Avanti Goniometer Adapter - 00851679007315

Trigno System Component
DELSYS, INC.
SP-W06-023
In Commercial Distribution

  • 00851679007315 ()


  • Psychophysiological biofeedback system

Trigno Avanti Analog Input Adapter - 00851679007308

Trigno System Component
DELSYS, INC.
SP-W06-025
In Commercial Distribution

  • 00851679007308 ()


  • Psychophysiological biofeedback system

Trigno Avanti FSR Adapter - 00851679007292

Trigno System Component
DELSYS, INC.
SP-W06-020
In Commercial Distribution

  • 00851679007292 ()


  • Psychophysiological biofeedback system

Trigno Avanti Spring Contact Adapter - 00851679007285

Trigno System Component
DELSYS, INC.
SP-W06-019
In Commercial Distribution

  • 00851679007285 ()


  • Psychophysiological biofeedback system

Trigno Avanti 12-inch Snap Lead EMG Sensor - 00851679007261

Trigno System Component
DELSYS, INC.
SP-W06-018B
In Commercial Distribution

  • 00851679007261 ()


  • Psychophysiological biofeedback system

Trigno Avanti Snap Lead EMG Sensor - 00851679007254

Trigno System Component
DELSYS, INC.
SP-W06-018A
In Commercial Distribution

  • 00851679007254 ()


  • Psychophysiological biofeedback system

Trigno Avanti Mini Sensor - 00851679007247

Trigno System Component
DELSYS, INC.
SP-W06-024
In Commercial Distribution

  • 00851679007247 ()


  • Psychophysiological biofeedback system

Trigno Quattro Sensor - 00851679007230

Trigno System Component
DELSYS, INC.
SP-W06-016
In Commercial Distribution

  • 00851679007230 ()


  • Psychophysiological biofeedback system

Trigno Galileo Sensor - 00851679007223

Trigno System Component
DELSYS, INC.
SP-W06-017
In Commercial Distribution

  • 00851679007223 ()


  • Psychophysiological biofeedback system

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system
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