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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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Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
In Commercial Distribution

  • 30093815708453 ()
  • 00093815708452 ()
  • 00093815000839 ()
70845

  • Electrical-only medical device connection cable, reusable
Abbott Diabetes Care USB Data Cable Software
ABBOTT DIABETES CARE INC
70845
Not in Commercial Distribution

  • 30093815000830 ()
  • 00093815000839 ()
  • 57599-0845-1 ()
70845

  • Electrical-only medical device connection cable, reusable
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 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 EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M00420020620
In Commercial Distribution

  • 08714729975700 ()
M00420020620

  • Cardiopulmonary physiological parameter analysis software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAL2US
In Commercial Distribution

  • B885MAML2US0 ()


  • X-ray image interpretive software
Radiological computer assisted detection and diagnosis software
THERAPIXEL
MAML
In Commercial Distribution

  • B885MAML0 ()
MAML

  • X-ray image interpretive software
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 Software Client w/ Desktop PC Bundle
Securitas Healthcare LLC
54390
In Commercial Distribution

  • 00840948102721 ()
54390

  • Fixed call button
NOEMODE 2.0 SOFTWARE, FINISHED GOOD, FACTORY INSTALL
Covidien LP
10122274
Not in Commercial Distribution

  • 10884521609181 ()


  • Ventilator application software
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 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
BD Pyxis CUBIE System (Software v1.X)
CAREFUSION 303, INC.
SW-CUBIE-V1
In Commercial Distribution

  • 10885403513824 ()


  • Anaesthesia cabinet
BD Pyxis MedBank (Cabinet Software v2.X)
CAREFUSION 303, INC.
SW-MB-CABINET-V2
In Commercial Distribution

  • 10885403513794 ()


  • Anaesthesia cabinet
BD Pyxis MedStation 4000 (Software v7.X)
CAREFUSION 303, INC.
SW-MS-4000-V7
In Commercial Distribution

  • 10885403513749 ()


  • Anaesthesia cabinet
BD Pyxis CIISafe ES (Software v1.X)
CAREFUSION 303, INC.
SW-CII-SAFE-ES-V1
In Commercial Distribution

  • 10885403513732 ()


  • Anaesthesia cabinet
LABSYSTEM™ PRO EP Review Workstation Software
BOSTON SCIENTIFIC CORPORATION
M004LSPRO400100
In Commercial Distribution

  • 00191506004392 ()
M004LSPRO400100

  • Cardiopulmonary physiological parameter analysis software
GoCheck Kids Native Software Application for Nokia.
Gobiquity, Inc.
Nokia 4.6.3
In Commercial Distribution

GCKNOK463

  • External ocular measurement camera
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
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