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

  • 00816734022887 ()
PRIZMSYS

  • Manometric gastrointestinal motility analysis system
PriZm® Upgrade Kit
DIVERSATEK HEALTHCARE, INC.
PRIZMUPG-KIT
In Commercial Distribution

  • 00816734022610 ()
PRIZMUPG-KIT

  • Manometric gastrointestinal motility analysis system
Z/pH Probe
DIVERSATEK HEALTHCARE, INC.
CZAN-BT-62
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system
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
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
Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZPI-BS-46
In Commercial Distribution

  • 00816734022368 ()
  • B019ZPIBS460 ()

  • Catheter Gauge: 6.9 French
ZPI-BS-46

  • Manometric gastrointestinal motility analysis system
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
Non-Infused Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZIN-BS-45E
In Commercial Distribution

  • 00816734022337 ()
  • B019ZINBS45E0 ()

  • Catheter Gauge: 6.4 French
ZIN-BS-45E

  • Manometric gastrointestinal motility analysis system
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