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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Software Installation, v.1.0
ST. JUDE MEDICAL, INC.
H702499
In Commercial Distribution

  • 05415067026149 ()
H702499

  • Cardiac mapping system application software
Module, v.1.0
ST. JUDE MEDICAL, INC.
AutoMap
In Commercial Distribution

  • 05415067026132 ()
H702498

  • Cardiac mapping system application software
Software Installation, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496
In Commercial Distribution

  • 05415067026125 ()
H702496

  • Cardiac mapping system application software
Software Installation, 30 day trial, v.2.0.0
ST. JUDE MEDICAL, INC.
H702496-T
In Commercial Distribution

  • 05415067026118 ()
H702496-T

  • Cardiac mapping system application software
Software Upgrade Kit, v.5.0.2
ST. JUDE MEDICAL, INC.
H702495
In Commercial Distribution

  • 05415067026101 ()
H702495

  • Cardiac mapping system application software
Cath Connect, Sensor Enabled
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067024275 ()
H702427

  • Cardiac mapping system application software
System Installation Tool
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067023841 ()
H702371

  • Cardiac mapping system application software
Utility Upgrade Kit
ST. JUDE MEDICAL, INC.
H702323
In Commercial Distribution

  • 05415067023230 ()
H702323

  • Cardiac mapping system application software
Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution

  • 05415067005861 ()
H700586

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution

  • 05415067002952 ()
H700295

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution

  • 05415067002938 ()
H700293

  • Cardiac mapping system application software
Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution

  • 05415067002921 ()
H700292

  • Cardiac mapping system application software
Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution

  • 05415067001863 ()
H700186

  • Cardiac mapping system application software
Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software
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
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1.1
In Commercial Distribution

  • 05415067053121 ()
ENSITE-SW-3.1.1

  • Cardiac mapping system application software
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
X EP System Advisor HD Grid X Mapping Catheter, Sensor Enabled Software License
ST. JUDE MEDICAL, INC.
ENSITE-HDGX-01
In Commercial Distribution

  • 05415067051103 ()
ENSITE-HDGX-01

  • Cardiac mapping system application software
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
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
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
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.0.2
In Commercial Distribution

  • 05415067050021 ()
ENSITE-TFM-3.0.2

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.0.2
In Commercial Distribution

  • 05415067050014 ()
ENSITE-SW-3.0.2

  • Cardiac mapping system application software
X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-02
In Commercial Distribution

  • 05415067049988 ()
ENSITE-OTAC-02

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-3.1
In Commercial Distribution

  • 05415067049711 ()
ENSITE-TFM-3.1

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-3.1
In Commercial Distribution

  • 05415067049704 ()
ENSITE-SW-3.1

  • Cardiac mapping system application software
X EP System Averaged Impedance Drop Software License
ST. JUDE MEDICAL, INC.
ENSITE-IMP-01
In Commercial Distribution

  • 05415067048400 ()
ENSITE-IMP-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Software License
ST. JUDE MEDICAL, INC.
ENSITE-FLEX-01
In Commercial Distribution

  • 05415067048394 ()
ENSITE-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-LS-01
In Commercial Distribution

  • 05415067048387 ()
ENSITE-D-LS-01

  • Cardiac mapping system application software
X EP System Averaged Impedance Drop Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-IMP-01
In Commercial Distribution

  • 05415067048370 ()
ENSITE-D-IMP-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-AMD-01
In Commercial Distribution

  • 05415067048363 ()
ENSITE-D-AMD-01

  • Cardiac mapping system application software
X EP System EnSite VoXel Flex Mode Demo Software License
ST. JUDE MEDICAL, INC.
ENSITE-D-FLEX-01
In Commercial Distribution

  • 05415067048356 ()
ENSITE-D-FLEX-01

  • Cardiac mapping system application software
X EP System LiveSync Software License
ST. JUDE MEDICAL, INC.
ENSITE-LS-01
In Commercial Distribution

  • 05415067048349 ()
ENSITE-LS-01

  • Cardiac mapping system application software
X EP System AutoMark Distance Software License
ST. JUDE MEDICAL, INC.
ENSITE-AMD-01
In Commercial Distribution

  • 05415067048332 ()
ENSITE-AMD-01

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Cath, SE Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-03
In Commercial Distribution

  • 05415067047861 ()
ENSITE-TFM-03

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-03
In Commercial Distribution

  • 05415067047854 ()
ENSITE-SW-03

  • Cardiac mapping system application software
Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software
X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0.1
In Commercial Distribution

  • 05415067046703 ()
ENSITE-SW-2.0.1

  • Cardiac mapping system application software
X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-TFM-02
In Commercial Distribution

  • 05415067046673 ()
ENSITE-TFM-02

  • Cardiac mapping system application software
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