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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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Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.1.3
In Commercial Distribution

  • 04041346100876 ()


  • Medical equipment clinical data interfacing software
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.3.x
In Commercial Distribution

  • 04041346102207 ()


  • Medical equipment clinical data interfacing software
Hypertension Management Software Version 6
IEM GmbH
HMS CS 6.2.x
Not in Commercial Distribution

  • 04041346102153 ()


  • Medical equipment clinical data interfacing software
MR Applications Software MP24 R01
GENERAL ELECTRIC COMPANY
MP24
Not in Commercial Distribution

  • 00840682107990 ()


  • Full-body MRI system, superconducting magnet
  • PET system
IE Sync Trigger Software Update
Covidien LP
980IESYNC
In Commercial Distribution

  • 10884521211551 ()


  • Ventilator application software
Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
PillCam Cloud reader Software V1.0
Given Imaging, Inc.
FGS-0707
In Commercial Distribution

  • 10884521836181 ()


  • Video capsule endoscopy system application software
Vital Sync Mobile Application Software
Covidien LP
VSMOBILEAPPSW01
In Commercial Distribution

  • 10884521815810 ()


  • Wireless patient monitor/sensor reporting software, layperson-use
SOFTWARE INW SERVER V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123563 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
VITAL SYNC Mobile V4 SOFTWARE
Covidien LP
VSMASW04
In Commercial Distribution

  • 10884521851559 ()


  • Multiparameter physiologic analysis workstation
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