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

  • 00816734022184 ()
  • B019Z0790000 ()
Z07-9000

  • Manometric gastrointestinal motility analysis system
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® 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® Manometry System
DIVERSATEK HEALTHCARE, INC.
ULTCART
In Commercial Distribution

  • 00816734022146 ()
  • B019ULTCART0 ()
ULTCART

  • Manometric gastrointestinal motility analysis system
Bioview® Manometry Acquisition Software
DIVERSATEK HEALTHCARE, INC.
S98-1925-7P1
In Commercial Distribution

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

  • Manometric gastrointestinal motility analysis system
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