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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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EnSite™ - 05415067037770

X EP System Omnipolar Technology Data Export Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTEXPORT-01
In Commercial Distribution

  • 05415067037770 ()
ENSITE-OTEXPORT-01

  • Cardiac mapping system application software

EnSite™ - 05415067037749

X EP System LiveView Dynamic Display Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LV-01
In Commercial Distribution

  • 05415067037749 ()
ENSITE-D-LV-01

  • Cardiac mapping system application software

EnSite™ - 05415067053145

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-03
In Commercial Distribution

  • 05415067053145 ()
ENSITE-D-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067051097

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-02
In Commercial Distribution

  • 05415067051097 ()
ENSITE-D-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050281

X EP System PFA Catheter Visualization Temporary Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FWV-01
In Commercial Distribution

  • 05415067050281 ()
ENSITE-D-FWV-01

  • Cardiac mapping system application software

Care Orchestrator Essence - 00606959062863

Care Orchestrator Essence, Medical equipment clinical data interfacing software
Respironics, Inc.
4.0.0
In Commercial Distribution

  • 00606959062863 ()
1135709

  • Medical equipment clinical data interfacing software

Eko Mobile App iOS - 00863609000334

iOS mobile device software for use with Eko products.
Eko Devices, Inc.
3.1.1
In Commercial Distribution

  • 00863609000334 ()


  • Medical equipment clinical data interfacing software

ACPlus Respiratory Assessment - 00858703006344

Software and sensor to provide assessment of respiratory capabilities.
ACCELERATED CARE PLUS CORP
ARASoftware
In Commercial Distribution

  • 00858703006344 ()


  • Pulmonary function analysis software, interpretive
  • Diagnostic spirometer, professional

HolterCare Editing Kit - 00856298006268

License dongle for second workstation using the HolterCare software.
SCOTTCARE CORPORATION, THE
HolterCare Editing Kit
In Commercial Distribution

  • 00856298006268 ()
100080

  • Electrocardiographic long-term ambulatory recording analyser application software

REMI - 00860005388172

REMI Mobile (Remote EEG Monitoring Software) - Ambulatory Use Module
Epitel, Inc.
1.x.x.x
Not in Commercial Distribution

  • 00860005388172 ()


  • Electroencephalographic monitoring system
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