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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® - 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

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

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 - 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 - 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 - 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

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 - 00816734022368

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

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 - 00816734022337

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

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 - 00816734022313

Single-Use Z/pH Probe (External Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BS-01E
In Commercial Distribution

  • 00816734022313 ()
  • B019ZANBS01E0 ()

  • Catheter Gauge: 6.4 French
ZAN-BS-01E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022306

Non-Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
ZAN-BS-01
In Commercial Distribution

  • 00816734022306 ()
  • B019ZANBS010 ()

  • Catheter Gauge: 6.4 French
ZAN-BS-01

  • 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 - 00816734022283

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

  • 00816734022283 ()
  • B019ZANBG440 ()

  • Catheter Gauge: 6.4 French
ZAN-BG-44

  • 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

Diversatek Healthcare - 00816734022269

Single-Use Z/pH Probe (External Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BS-01E
In Commercial Distribution

  • 00816734022269 ()
  • B019ZAIBS01E0 ()

  • Catheter Gauge: 6.9 French
ZAI-BS-01E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022252

Infused Single-Use Z/pH Probe (Internal Reference), Single pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BS-01
In Commercial Distribution

  • 00816734022252 ()
  • B019ZAIBS010 ()

  • Catheter Gauge: 6.9 French
ZAI-BS-01

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022245

LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BL-56
In Commercial Distribution

  • 00816734022245 ()
  • B019ZAIBL560 ()

  • Catheter Gauge: 6.9 French
ZAI-BL-56

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022238

LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BL-55
In Commercial Distribution

  • 00816734022238 ()
  • B019ZAIBL550 ()

  • Catheter Gauge: 6.9 French
ZAI-BL-55

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022221

LPR Probe, Dual pH (Esophageal), LPR Acid, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BL-54
In Commercial Distribution

  • 00816734022221 ()
  • B019ZAIBL540 ()

  • Catheter Gauge: 6.9 French
ZAI-BL-54

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022214

Single-Use Z/pH Probe (External Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BG-44E
In Commercial Distribution

  • 00816734022214 ()
  • B019ZAIBG44E0 ()

  • Catheter Gauge: 6.9 French
ZAI-BG-44E

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022207

Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Gastric and Esophageal), Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BG-44
In Commercial Distribution

  • 00816734022207 ()
  • B019ZAIBG440 ()

  • Catheter Gauge: 6.9 French
ZAI-BG-44

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022191

Infused Single-Use Z/pH Probe (Internal Reference), Dual pH (Esophageal) with LES Locator, Locator Port 6cm
DIVERSATEK HEALTHCARE, INC.
ZAI-BD-31
In Commercial Distribution

  • 00816734022191 ()
  • B019ZAIBD310 ()

  • Catheter Gauge: 6.9 French
ZAI-BD-31

  • Manometric gastrointestinal motility analysis system

ZepHr - 00816734022184

ZepHr® System Kit
DIVERSATEK HEALTHCARE, INC.
Z07-9000
In Commercial Distribution

  • 00816734022184 ()
  • B019Z0790000 ()
Z07-9000

  • Manometric gastrointestinal motility analysis system

ZepHr - 00816734022177

ZepHr® Z/pH Recorder
DIVERSATEK HEALTHCARE, INC.
Z07-2000-B-B
In Commercial Distribution

  • 00816734022177 ()
  • B019Z072000BB0 ()
Z07-2000-B-B

  • Manometric gastrointestinal motility analysis system

ZepHr - 00816734022160

ZepHr® pH Recorder
DIVERSATEK HEALTHCARE, INC.
Z07-2000-B-A
In Commercial Distribution

  • 00816734022160 ()
  • B019Z072000BA0 ()
Z07-2000-B-A

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734022153

InSIGHT Ultima® Manometry System
DIVERSATEK HEALTHCARE, INC.
ULTSYS
In Commercial Distribution

  • 00816734022153 ()
  • B019ULTSYS0 ()
ULTSYS

  • Manometric gastrointestinal motility analysis system

inSIGHT Ultima - 00816734022146

inSIGHT Ultima® Manometry System
DIVERSATEK HEALTHCARE, INC.
ULTCART
In Commercial Distribution

  • 00816734022146 ()
  • B019ULTCART0 ()
ULTCART

  • Manometric gastrointestinal motility analysis system

Bioview - 00816734022139

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

  • 00816734022139 ()
  • B019S9819257P10 ()
S98-1925-7P1

  • Manometric gastrointestinal motility analysis system

Bioview - 00816734022122

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-6P1
In Commercial Distribution

  • 00816734022122 ()
  • B019S9819256P10 ()
S98-1925-6P1

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022115

Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-5P1
In Commercial Distribution

  • 00816734022115 ()
  • B019S9819255P10 ()
S98-1925-5P1

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022108

Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
PHNS-P
In Commercial Distribution

  • 00816734022108 ()
  • B019PHNSP0 ()

  • Catheter Gauge: 5 French
PHNS-P

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022092

Single-Use pH Probe, Non-Infused, Single pH (Esophageal)
DIVERSATEK HEALTHCARE, INC.
PHNS
In Commercial Distribution

  • 00816734022092 ()
  • B019PHNS0 ()

  • Catheter Gauge: 6.4 French
PHNS

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022085

Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) with LES Port
DIVERSATEK HEALTHCARE, INC.
PHN5
In Commercial Distribution

  • 00816734022085 ()
  • B019PHN50 ()

  • Catheter Gauge: 6.4 French
PHN5

  • Manometric gastrointestinal motility analysis system

Diversatek Healthcare - 00816734022078

Single-Use pH Probe, Non-Infused, Dual pH (Esophageal) 21cm Spacing
DIVERSATEK HEALTHCARE, INC.
PHN21
In Commercial Distribution

  • 00816734022078 ()
  • B019PHN210 ()

  • Catheter Gauge: 6.4 French
PHN21

  • Manometric gastrointestinal motility analysis system
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