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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™ - 05415067042477

X EP System Advanced Mapping Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AM-2.0
In Commercial Distribution

  • 05415067042477 ()
ENSITE-D-AM-2.0

  • Cardiac mapping system application software

EnSite™ - 05415067038111

X EP System Wave Speed Map Software License
ST. JUDE MEDICAL, INC.
ENSITE-WS-01
In Commercial Distribution

  • 05415067038111 ()
ENSITE-WS-01

  • Cardiac mapping system application software

EnSite™ - 05415067037718

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

  • 05415067037718 ()
ENSITE-LV-01

  • Cardiac mapping system application software

EnSite™ - 05415067037695

X EP System Omnipolar Technology Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-OT-01
In Commercial Distribution

  • 05415067037695 ()
ENSITE-D-OT-01

  • Cardiac mapping system application software

EnSite™ - 05415067026200

Software Upgrade Kit, 30 day license, v.2.0
ST. JUDE MEDICAL, INC.
Contact Force Module
In Commercial Distribution

  • 05415067026200 ()
H702500-T

  • Cardiac mapping system application software

EnSite™ - 05415067053138

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

  • 05415067053138 ()
ENSITE-FWV-03

  • Cardiac mapping system application software

EnSite™ - 05415067051110

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

  • 05415067051110 ()
ENSITE-FWV-02

  • Cardiac mapping system application software

EnSite™ - 05415067050298

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

  • 05415067050298 ()
ENSITE-FWV-01

  • Cardiac mapping system application software

Reader Control v2.2 - 00858637005833

Reader Control v2.2 for Exact Sciences System Software
EXACT SCIENCES CORPORATION
2.2
In Commercial Distribution

  • 00858637005833 ()


  • Laboratory instrument/analyser application software IVD

PatientCare Platform - 00852132007286

Platform software application for data collection and analysis
PREVENTICE TECHNOLOGIES, INC.
SW1001
In Commercial Distribution

  • 00852132007286 ()


  • Cardiopulmonary physiological parameter analysis software
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