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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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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

PriZm - 00816734023075

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

  • 00816734023075 ()
PRIZMCART-II

  • Manometric gastrointestinal motility analysis system

PriZm - 00816734023068

PriZm® Central Unit
DIVERSATEK HEALTHCARE, INC.
H20-4500
In Commercial Distribution

  • 00816734023068 ()
H20-4500

  • Manometric gastrointestinal motility analysis system

Ultima - 00816734023013

Ultima Cable for HRCA Manometry Probe (Lemo Connector)
DIVERSATEK HEALTHCARE, INC.
H12R-7210
In Commercial Distribution

  • 00816734023013 ()
H12R-7210

  • Manometric gastrointestinal motility analysis system

Ultima - 00816734023006

Ultima Cable for High Resolution Manometry Probe
DIVERSATEK HEALTHCARE, INC.
H12R-7110
In Commercial Distribution

  • 00816734023006 ()
H12R-7110

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734022931

MiVu Mucosal Integrity Starter Kit
DIVERSATEK HEALTHCARE, INC.
MIVU-KIT
In Commercial Distribution

  • 00816734022931 ()
MIVU-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022924

Zvu® HRAM Starter Kit
DIVERSATEK HEALTHCARE, INC.
HRAM-200-17-KIT
In Commercial Distribution

  • 00816734022924 ()

  • Catheter Gauge: 17 French
HRAM-200-17-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022917

Zvu® HRiM Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIM-201-12-KIT
In Commercial Distribution

  • 00816734022917 ()

  • Catheter Gauge: 12 French
HRIM-201-12-KIT

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734022900

MiVu Mucosal Integrity Inflation Syringe and Extension Tubing
DIVERSATEK HEALTHCARE, INC.
MI-SYR-01
In Commercial Distribution

  • 00816734022900 ()
  • 10816734022907 ()
MI-SYR-01

  • Manometric gastrointestinal motility analysis system

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

Diversatek Healthcare - 00816734022405

Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-46E
In Commercial Distribution

  • 00816734022405 ()
  • B019ZPNBS46E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022382

Non-Infused Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BG-07E
In Commercial Distribution

  • 00816734022382 ()
  • B019ZPNBG07E0 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-07E

  • Manometric gastrointestinal motility analysis system
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