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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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MiVu - 00816734022948

PriZm Upgrade Kit for MiVu Mucosal Integrity
DIVERSATEK HEALTHCARE, INC.
PRIZM-KIT
In Commercial Distribution

  • 00816734022948 ()
PRIZM-KIT

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022757

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H12R-2500
In Commercial Distribution

  • 00816734022757 ()
H12R-2500

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022740

HRAM Protocol for BioView
DIVERSATEK HEALTHCARE, INC.
HRAM-100
In Commercial Distribution

  • 00816734022740 ()
HRAM-100

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022733

Zvu® HRAM Probe
DIVERSATEK HEALTHCARE, INC.
HRAM-200
In Commercial Distribution

  • 00816734022733 ()

  • Catheter Gauge: 17 French
HRAM-200

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734022719

MiVu Mucosal Integrity Regulator
DIVERSATEK HEALTHCARE, INC.
MI-REG-01
In Commercial Distribution

  • 00816734022719 ()
MI-REG-01

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022689

Zvu® HRiM Probe
DIVERSATEK HEALTHCARE, INC.
HRIM-201
In Commercial Distribution

  • 00816734022689 ()

  • Catheter Gauge: 12 French
HRIM-201

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022610

PriZm® Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZMUPG-KIT
In Commercial Distribution

  • 00816734022610 ()
PRIZMUPG-KIT

  • Manometric gastrointestinal motility analysis system

Zvu - 00816734022429

Zvu® Advanced GI Diagnostic Software
DIVERSATEK HEALTHCARE, INC.
ZVU-2016
In Commercial Distribution

  • 00816734022429 ()
  • B019ZVU20160 ()
ZVU-2016

  • Manometric gastrointestinal motility analysis system

ZepHr - 00816734022184

ZepHr® System Kit
DIVERSATEK HEALTHCARE, INC.
Z07-9000
In Commercial Distribution

  • 00816734022184 ()
  • B019Z0790000 ()
Z07-9000

  • Manometric gastrointestinal motility analysis system

ZepHr - 00816734022177

ZepHr® Z/pH Recorder
DIVERSATEK HEALTHCARE, INC.
Z07-2000-B-B
In Commercial Distribution

  • 00816734022177 ()
  • B019Z072000BB0 ()
Z07-2000-B-B

  • Manometric gastrointestinal motility analysis system
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