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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 - 00816734021903

Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 250ml
DIVERSATEK HEALTHCARE, INC.
D82-3181
In Commercial Distribution

  • 00816734021903 ()
  • B019D8231810 ()
D82-3181

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021897

Buffer Solution, pH 7.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3152
In Commercial Distribution

  • 00816734021897 ()
  • B019D8231520 ()
D82-3152

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021880

Buffer Solution, pH 4.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3151
In Commercial Distribution

  • 00816734021880 ()
  • B019D8231510 ()
D82-3151

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021873

Buffer Solution, pH 1.0 +/- 0.05 @ 25C, 500ml
DIVERSATEK HEALTHCARE, INC.
D82-3103
In Commercial Distribution

  • 00816734021873 ()
  • B019D8231030 ()
D82-3103

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021866

Motility Cart for inSIGHT Ultima® and PriZm Motility Systems
DIVERSATEK HEALTHCARE, INC.
CART5R
In Commercial Distribution

  • 00816734021866 ()
  • B019CART5R0 ()
CART5R

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021859

Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-5070
In Commercial Distribution

  • 10816734021856 ()
  • 00816734021859 ()
  • B019A8650700 ()
A86-5070

  • Manometric gastrointestinal motility analysis system

MiVu - 00816734021842

MiVu Mucosal Integrity Cable
DIVERSATEK HEALTHCARE, INC.
MI-CAB-01
In Commercial Distribution

  • 00816734021842 ()
MI-CAB-01

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021835

Anorectal Balloon, 400CC TPE
DIVERSATEK HEALTHCARE, INC.
A86-4300-10
In Commercial Distribution

  • 10816734021832 ()
  • 00816734021835 ()
  • B019A864300100 ()
A86-4300-10

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021828

Air Charged Adapter Cable
DIVERSATEK HEALTHCARE, INC.
GIS-7010
In Commercial Distribution

  • 00816734021828 ()
GIS-7010

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021682

Anorectal Balloon
DIVERSATEK HEALTHCARE, INC.
A86-1070
In Commercial Distribution

  • 10816734021689 ()
  • 00816734021682 ()
  • B019A8610700 ()
A86-1070

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021675

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04-2000-S
In Commercial Distribution

  • 00816734021675 ()
  • B019A042000S0 ()
A04-2000-S

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021668

Sphincter Locator
DIVERSATEK HEALTHCARE, INC.
A04R-2500
In Commercial Distribution

  • 00816734021668 ()
  • B019A04R25000 ()
A04R-2500

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021545

HRaM Syringe/Stopcock Kit
DIVERSATEK HEALTHCARE, INC.
A86-4120
In Commercial Distribution

  • 00816734021545 ()
  • B019A8641200 ()
A86-4120

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021538

Polyurethane Bands (Disk of 20 Bands) for HRaM catheters
DIVERSATEK HEALTHCARE, INC.
A86-4100
In Commercial Distribution

  • 00816734021538 ()
  • B019A8641000 ()
A86-4100

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734021514

HRaM Kit includes 10 anorectal balloons, 20 polyurethane bands, and a suture removal kit
DIVERSATEK HEALTHCARE, INC.
A86-4110-10
In Commercial Distribution

  • 00816734021514 ()
  • B019A864110100 ()
A86-4110-10

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023488

Desktop PC with Zvu Software
DIVERSATEK HEALTHCARE, INC.
COMP-KIT
In Commercial Distribution

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023471

Anal Sphincter Electromyography Kit
DIVERSATEK HEALTHCARE, INC.
EMG-KIT
In Commercial Distribution

  • 00816734023471 ()
EMG-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023457

HRiM SD High Resolution Impedance Manometry Probe Kit
DIVERSATEK HEALTHCARE, INC.
HRIMSD-KIT
In Commercial Distribution

  • 00816734023457 ()
HRIMSD-KIT

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734023433

Manometry Starter Kit
DIVERSATEK HEALTHCARE, INC.
MANO-KIT
In Commercial Distribution

  • 00816734023433 ()
MANO-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734023426

Zvu® Functional GI Software Revision 3.4.0
DIVERSATEK HEALTHCARE, INC.
ZVU-3 Revision 3.4.0
In Commercial Distribution

  • 00816734023426 ()
ZVU-3

  • Manometric gastrointestinal motility analysis system

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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