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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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Welch Allyn, Inc. - 00817655020952

Hscribe Web Upload software kit
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00817655020952 ()
88188-001-50

  • Centralized patient monitor

Diversatek Healthcare - 00816734023488

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

  • 00816734023488 ()
COMP-KIT

  • Manometric gastrointestinal motility analysis system

Zvu® - 00816734022825

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

  • 00816734022825 ()
ZVU-3

  • 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

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741231124

Site~Rite 9 Ultrasound Software
Bard Access Systems, Inc.
SR9v1.1.0
In Commercial Distribution

  • 00801741231124 ()
SR9v1.1.0

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

Sherlock 3CG+, BD SiteRite 9 Ultrasound System - 00801741219221

SiteRite 9 Sherlock Software v3.3.1
Bard Access Systems, Inc.
Sherlockv3.3.1
In Commercial Distribution

  • 00801741219221 ()
Sherlockv3.3.1

  • Central venous catheter navigation system, electrocardiographic/magnetic
  • General-purpose ultrasound imaging system

PillCam - 07290110360795

PillCam™ Remote Reading Software
Given Imaging, Inc.
FGS-0665
In Commercial Distribution

  • 07290110360795 ()


  • Video capsule endoscopy system application software

IH-Com V5.0 - 07611969234417

IH-Com V5.0, Software Version 5.0.10
Bio-Rad Medical Diagnostics GmbH
5.0.10
In Commercial Distribution

  • 07611969234417 ()
009101

  • Laboratory instrument/analyser application software IVD
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