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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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Diversatek Healthcare - 00816734021545

HRaM Syringe/Stopcock Kit
DIVERSATEK HEALTHCARE, INC.
A86-4120
In Commercial Distribution

  • 00816734021545 ()
  • B019A8641200 ()
A86-4120

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021538

Polyurethane Bands (Disk of 20 Bands) for HRaM catheters
DIVERSATEK HEALTHCARE, INC.
A86-4100
In Commercial Distribution

  • 00816734021538 ()
  • B019A8641000 ()
A86-4100

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021514

HRaM Kit includes 10 anorectal balloons, 20 polyurethane bands, and a suture removal kit
DIVERSATEK HEALTHCARE, INC.
A86-4110-10
In Commercial Distribution

  • 00816734021514 ()
  • B019A864110100 ()
A86-4110-10

  • Manometric gastrointestinal motility analysis system

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 - 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 - 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

PriZm - 00816734022993

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4000
In Commercial Distribution

  • 00816734022993 ()
H20-4000

  • Manometric gastrointestinal motility analysis system
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