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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 - 00093815708452

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 - 00093815000839

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

Welch Allyn, Inc. - 00817655021058

Resting ECG connectivity gateway software v.5.0.0
WELCH ALLYN, INC.
901147
Not in Commercial Distribution

  • 00817655021058 ()
11027-024-50

  • Electrocardiograph, professional, multichannel

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

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

BD Pyxis - 10885403513824

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

  • 10885403513824 ()


  • Anaesthesia cabinet

BD Pyxis - 10885403513794

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

  • 10885403513794 ()


  • Anaesthesia cabinet
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