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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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Zvu® - 00816734022894

Replacement Cable for Zvu® HRiM and HRaM Probes
DIVERSATEK HEALTHCARE, INC.
H12R-7610
In Commercial Distribution

  • 00816734022894 ()
H12R-7610

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022887

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

  • 00816734022887 ()
PRIZMSYS

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734022870

PriZm Base Cart System
DIVERSATEK HEALTHCARE, INC.
PRIZMCART
In Commercial Distribution

  • 00816734022870 ()
PRIZMCART

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022863

Zvu® Anorectal Manometry Procedure Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-PROC-10
In Commercial Distribution

  • 00816734022863 ()
HRAM-PROC-10

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022856

Zvu® Anorectal Balloons
DIVERSATEK HEALTHCARE, INC.
HRAM-BAL-10
In Commercial Distribution

  • 00816734022856 ()
HRAM-BAL-10

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022825

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

  • 00816734022825 ()
ZVU-3

  • 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

Diversatek Healthcare - 00816734022726

Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BG-57
In Commercial Distribution

  • 00816734022726 ()
  • B019ZPNBG570 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-57

  • Manometric gastrointestinal motility analysis system
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