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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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SynGenX®-1000 - B039SGI03050

SynGenX®-1000 Disposable Cartridge
Thermogenesis Corp.
SGI-0305
In Commercial Distribution

  • B039SGI03050 ()
  • B039SGI03051 ()
  • B039SGI03059 ()


  • Umbilical cord blood collection set

SynGenX®-1000 - B039SGI0120010

SynGenX®-1000 Docking Station
Thermogenesis Corp.
SGI-0120-01
In Commercial Distribution

  • B039SGI0120010 ()
  • B039SGI0120011 ()


  • Noninvasive device battery charger

CryoPRO™-2 - B039SGI00910

CryoPRO™-2 Cryopreservation/Storage Bag Set
Thermogenesis Corp.
SGI-0091
In Commercial Distribution

  • B039SGI00911 ()
  • B039SGI00910 ()
  • B039SGI00919 ()


  • Blood cell freeze/thaw system

SynGenX®-1000 - B039SGI0046010

SynGenX®-1000 Control Module
Thermogenesis Corp.
SGI-0046-01
In Commercial Distribution

  • B039SGI0046010 ()
  • B039SGI0046011 ()


  • Blood component separator, automated

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

SUDOSCAN® - B122S2MU0

SUDOSCAN2 Master unit
IMPETO MEDICAL
SUDOSCAN2
Not in Commercial Distribution

  • B122S2MU0 ()
S2MU

  • Skin electrical conductance meter

SUDOSCAN® - B122DSP0

Smart electrodes
IMPETO MEDICAL
DSP
Not in Commercial Distribution

  • B122DSP0 ()
DSP

  • Skin electrical conductance meter

SUDOSCAN® - B122APH20

Hand electrodes standard
IMPETO MEDICAL
APH2
Not in Commercial Distribution

  • B122APH20 ()
APH2

  • Skin electrical conductance meter

SUDOSCAN® - B122APF20

Foot electrodes standard
IMPETO MEDICAL
APF2
Not in Commercial Distribution

  • B122APF20 ()
APF2

  • Skin electrical conductance meter

SUDOSCAN® - B122ADSPHD0

SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes Dock Smart Electrodes USB cable A software application
IMPETO MEDICAL
SUDOSCAN S
Not in Commercial Distribution

  • B122ADSPHD0 ()
ADSPHD

  • Skin electrical conductance meter
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