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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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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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