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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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Pyxis - 10885403421532

Pyxis Transfusion Verification
CAREFUSION 303, INC.
TRANSFUSION
Not in Commercial Distribution

  • 10885403421532 ()


  • Blood bank information system application software

Lunit INSIGHT CXR Triage - 08800076000124

Linux version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000124 ()


  • X-ray image interpretive software

Heuron ICH - 08800086200217

No Description
Heuron Co., Ltd.
ST-ICT01
In Commercial Distribution

  • 08800086200217 ()


  • Radiology DICOM image processing application software

Lunit INSIGHT CXR Triage - 08800076000179

Lunit INSIGHT CXR Triage - Windows version
Lunit Inc.
1.0
In Commercial Distribution

  • 08800076000179 ()


  • X-ray image interpretive software

syngo.CT Brain Hemorrhage - 04056869267456

No Description
Siemens Healthcare GmbH
11546320
In Commercial Distribution

  • 04056869267456 ()


  • CT system application software

ImmuLINK - 10888234002475

ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user’s Laboratory Information System (LIS). ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
IMMUCOR, INC.
0030311
In Commercial Distribution

  • 10888234002475 ()


  • Laboratory instrument/analyser application software IVD

Critical Care Suite - 00195278217981

Critical Care Suite 2.0, Designated Medical Device
GE MEDICAL SYSTEMS, INC.
2.0
In Commercial Distribution

  • 00195278217981 ()


  • X-ray image interpretive software

Irregular Rhythm Notification feature 2.0 - 00194252456774

Irregular Rhythm Notification feature Watch App (Version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution

  • 00194252456774 ()


  • Self-care monitoring/reporting software

Atrial Fibrillation History Feature - 00194252456804

Atrial Fibrillation History Feature Watch app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456804 ()


  • Self-care monitoring/reporting software

Atrial Fibrillation History Feature - 00194252456798

Atrial Fibrillation History Feature iPhone app
APPLE INC.
Feature version 1.x
In Commercial Distribution

  • 00194252456798 ()


  • Self-care monitoring/reporting software
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