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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 - 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

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

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

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

Diversatek Healthcare - 00816734022467

Z/pH Probe
DIVERSATEK HEALTHCARE, INC.
CZAN-BT-62
In Commercial Distribution

  • 00816734022467 ()
  • B019CZANBT620 ()
CZAN-BT-62

  • 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

Diversatek Healthcare - 00816734022412

Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZPN-BS-50
In Commercial Distribution

  • 00816734022412 ()
  • B019ZPNBS500 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-50

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022399

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

  • 00816734022399 ()
  • B019ZPNBS460 ()

  • Catheter Gauge: 6.4 French
ZPN-BS-46

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022375

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

  • 00816734022375 ()
  • B019ZPNBG070 ()

  • Catheter Gauge: 6.4 French
ZPN-BG-07

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022351

Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZPI-BG-52
In Commercial Distribution

  • 00816734022351 ()
  • B019ZPIBG520 ()

  • Catheter Gauge: 6.9 French
ZPI-BG-52

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022344

Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-51
In Commercial Distribution

  • 00816734022344 ()
  • B019ZINBS510 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-51

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022320

Non-Infused Single-Use Z/pH Probe (Internal Reference), Triple Sensor
DIVERSATEK HEALTHCARE, INC.
ZAN-BT-60
In Commercial Distribution

  • 00816734022320 ()
  • B019ZANBT600 ()

  • Catheter Gauge: 6.4 French
ZAN-BT-60

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022290

Single-Use Z/pH Probe (External Reference), Dual pH (Gastric & Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BG-44E
In Commercial Distribution

  • 00816734022290 ()
  • B019ZANBG44E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BG-44E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022276

Non-Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BD-31
In Commercial Distribution

  • 00816734022276 ()
  • B019ZANBD310 ()

  • Catheter Gauge: 6.4 French
ZAN-BD-31

  • Manometric gastrointestinal motility analysis system
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