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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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Advance Biometrix - B353AB12571

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1257
Not in Commercial Distribution

  • B353AB12572 ()
  • B353AB12571 ()
  • B353AB12573 ()
AB1257_US

  • Electrocardiographic ambulatory recorder

Advance Biometrix - B353AB12511

Wearable Biosensor - ECG Remote Monitoring Biosensor
Lifesignals, Inc.
AB1251
Not in Commercial Distribution

  • B353AB12512 ()
  • B353AB12511 ()
  • B353AB12513 ()
AB1251_US

  • Electrocardiographic ambulatory recorder

Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023471

Anal Sphincter Electromyography Kit
DIVERSATEK HEALTHCARE, INC.
EMG-KIT
In Commercial Distribution

  • 00816734023471 ()
EMG-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023464

High Resolution Anorectal Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-KIT
In Commercial Distribution

  • 00816734023464 ()
HRAM-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023457

HRiM SD High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIMSD-KIT
In Commercial Distribution

  • 00816734023457 ()
HRIMSD-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023440

HRiM2 High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-KIT
In Commercial Distribution

  • 00816734023440 ()
HRIM-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023433

Manometry Starter Kit
DIVERSATEK HEALTHCARE, INC.
MANO-KIT
In Commercial Distribution

  • 00816734023433 ()
MANO-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734023426

Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023341

ZepHr Pack
DIVERSATEK HEALTHCARE, INC.
Z07-PACK
In Commercial Distribution

  • 00816734023341 ()
Z07-PACK

  • Manometric gastrointestinal motility analysis system
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