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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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Kangaroo - 10885380198786

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

  • 10885380198786 ()
1000NT-H

  • 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

Freespira - B185SM40500

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.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system

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

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
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