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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 Class Implantable

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FST5 - B185FS059370

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
5
In Commercial Distribution

  • B185FS059370 ()


  • Psychophysiological biofeedback system

Kangaroo - 50885380198791

Kangaroo NTrainer Handpiece Tubing
Cardinal Health 200, LLC
1000NT-T
In Commercial Distribution

  • 10885380198793 ()
  • 50885380198791 ()
1000NT-T

  • Psychophysiological biofeedback system

NTRAINER - 50885380195561

NTrainer System 2.0 Patient Receiver Tubes (10-pack)
Cardinal Health 200, LLC
510NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195561 ()
510NT

  • Psychophysiological biofeedback system

NTRAINER - 50885380195554

NTrainer System 2.0 Patient Receiver Tubes (5-pack)
Cardinal Health 200, LLC
505NT
In Commercial Distribution

  • 10885380195556 ()
  • 50885380195554 ()
505NT

  • Psychophysiological biofeedback system

Resilience – By Inner Armor App iOS - 07540191000630

No Description
Thought Technology Ltd.
SA4515
In Commercial Distribution

  • 07540191000630 ()


  • Psychophysiological biofeedback system

eVu Senz App iOS - 07540191000623

No Description
Thought Technology Ltd.
SA4520
In Commercial Distribution

  • 07540191000623 ()


  • Psychophysiological biofeedback system

Vaginal Pressure Probe - 07540191000616

No Description
Thought Technology Ltd.
SA9005
In Commercial Distribution

  • 07540191000616 ()


  • Psychophysiological biofeedback system

Pressure Sensor - 07540191000609

No Description
Thought Technology Ltd.
SA9003
In Commercial Distribution

  • 07540191000609 ()


  • Psychophysiological biofeedback system

NEUROINFINITI 2 - 07540191000562

No Description
Thought Technology Ltd.
SA7904
In Commercial Distribution

  • 07540191000562 ()


  • Psychophysiological biofeedback system

Dual Sensitivity Meter - 07540191000531

No Description
Thought Technology Ltd.
SA2076
In Commercial Distribution

  • 07540191000531 ()


  • Psychophysiological biofeedback system
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