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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 - 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

MiVu - 00816734023167

MiVu Endo Cap Cable
DIVERSATEK HEALTHCARE, INC.
MI-CAB-02
In Commercial Distribution

  • 00816734023167 ()
MI-CAB-02

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734023143

MiVu Esophageal Endo Cap
DIVERSATEK HEALTHCARE, INC.
MI-ESO-CAP-3L
In Commercial Distribution

  • 00816734023143 ()
MI-ESO-CAP-3L

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023112

inSIGHT Ultima Base System
DIVERSATEK HEALTHCARE, INC.
ULTSYS-II
In Commercial Distribution

  • 00816734023112 ()
ULTSYS-II

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734023105

inSIGHT Ultima Base Cart System
DIVERSATEK HEALTHCARE, INC.
ULTCART-II
In Commercial Distribution

  • 00816734023105 ()
ULTCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023099

PriZm Base System
DIVERSATEK HEALTHCARE, INC.
PRIZMSYS-II
In Commercial Distribution

  • 00816734023099 ()
PRIZMSYS-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023082

PriZm Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZM-KIT-II
In Commercial Distribution

  • 00816734023082 ()
PRIZM-KIT-II

  • Manometric gastrointestinal motility analysis system
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