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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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Compumedics Grael - 09342451001825

Grael EEG v2 System with EEG software
COMPUMEDICS LIMITED
Grael EEG
In Commercial Distribution

  • 09342451001825 ()
9028-0004-02

  • Electroencephalograph

Dexcom G5 Mobile Android App - 00386270000293

G5 Mobile Android App Stand Alone Software
Dexcom, Inc.
SW10940
In Commercial Distribution

  • 00386270000293 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Dexcom G5 Mobile IOS App - 00386270000002

G5 Mobile IOS App Stand Alone Software
Dexcom, Inc.
SW10611
In Commercial Distribution

  • 00386270000002 ()


  • Percutaneous interstitial fluid glucose monitoring system, electrochemical

Baha Fitting Software 7 - 09321502075527

VA version of Baha Fitting Software 7
Cochlear Bone Anchored Solutions AB
V 7.0
In Commercial Distribution

  • 09321502075527 ()
P2121915

  • Hearing aid wireless-fitting computer-aided set

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

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

ARIAL - 00840948102721

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

  • 00840948102721 ()
54390

  • Fixed call button

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

Puritan Bennett - 10884521609181

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

  • 10884521609181 ()


  • Ventilator application software
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