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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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Geenius - 03610522162260

Geenius Software V2.0 LIS Guide, US only
Bio-RAD Laboratories, Inc.
12012484
In Commercial Distribution

  • 03610522162260 ()

  • 1 Each
12012484

  • HIV1/HIV2 antibody IVD, kit, chemiluminescent immunoassay

IH-Com - 03610520569870

IH-Com Kit Fullversion US; Software Version: 04.0.27.
Bio-Rad Medical Diagnostics GmbH
04.0.27
In Commercial Distribution

  • 03610520569870 ()
009100

  • Laboratory instrument/analyser application software IVD

LABSYSTEM™ PRO - 08714729975700

LABSYSTEM™ PRO EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M00420020620
In Commercial Distribution

  • 08714729975700 ()
M00420020620

  • Cardiopulmonary physiological parameter analysis software

MammoScreen - B885MAML2US0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software

MammoScreen - B885MAML0

Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software

Vmax - 10846446027600

SOFTWARE KIT,VMAX ENCORE VERSION 20-5B CD
Carefusion Corporation
63654
Not in Commercial Distribution

  • 10846446027600 ()
63654

  • Pulmonary function analysis system, paediatric
  • Pulmonary function analysis system, adult

ARIAL - 00840948102721

Arial Software Client w/ Desktop PC Bundle
Securitas Healthcare LLC
54390
In Commercial Distribution

  • 00840948102721 ()
54390

  • Fixed call button

Puritan Bennett - 10884521609181

NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122274
Not in Commercial Distribution

  • 10884521609181 ()


  • Ventilator application software

AIDA compact - 04048551032558

AIDA compact II Software HD (v.2.3)
Karl Storz GmbH & Co. KG
20040402-15
In Commercial Distribution

  • 04048551032558 ()


  • Operating room audiovisual data/device management system application software

AIDA compact - 04048551060049

AIDA compact II Software Upgrade (v.2.4
Karl Storz GmbH & Co. KG
20040502-U02
In Commercial Distribution

  • 04048551060049 ()


  • Operating room audiovisual data/device management system application software
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