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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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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

Irregular Rhythm Notification feature 2.0 - 00194252456781

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

  • 00194252456781 ()


  • Self-care monitoring/reporting software

Vista ® - 05020583252035

Vista® Information System Version 4 Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25203
In Commercial Distribution

  • 05020583252035 ()


  • Blood bank information system

Vista® - 05020583252028

Information System Version 4, Vista Standard Interface and SafeTrace® BBSI Installation Guide
TERUMO BCT, INC.
25202
In Commercial Distribution

  • 05020583252028 ()


  • Blood bank information system

Vista ® - 05020583252011

Vista Information System, Version 4.2
TERUMO BCT, INC.
25201
In Commercial Distribution

  • 05020583252011 ()


  • Blood bank information system

TOMEs TERUMO OPERATIONAL MEDICAL EQUIPMENT SOFTWARE - 05020583114012

TOMEs Terumo Operational Medical Equipment Software Version 7.3
TERUMO BCT, INC.
11401
In Commercial Distribution

  • 05020583114012 ()
11401

  • Blood bank information system application software

InferRead CT Stroke.AI - 00850003095011

InferRead CT Stroke.AI is a radiological computer aided triage and notification software for use in the analysis of non-enhanced head CT images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging suspected positive findings of intracranial hemorrhage (ICH).
Infervision US Inc
1.1.0.0
In Commercial Distribution

  • 00850003095011 ()


  • Diagnostic x-ray digital imaging system workstation
  • X-ray image interpretive software
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