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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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IC Output Cable
ST. JUDE MEDICAL, INC.
ENSITE-WM56-144-01
In Commercial Distribution

  • 05415067033642 ()

  • Length: 366.0000 Centimeter
ENSITE-WM56-144-01

  • Electrical-only medical device connection cable, reusable
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
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
Cathvision ApS
CVT-0069 R3.0
Not in Commercial Distribution

  • 05700002168535 ()
CVT-0069 R3.0 ECGenius System

  • Cardiac electrophysiology analysis system
The ECGenius System is a computerized electrophysiology measurement system designed for both regular and experimental EP studies.The ECGenius System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
Cathvision ApS
CVT-0069 R2.0
Not in Commercial Distribution

  • 05700002168528 ()
CVT-0069 R2.0 ECGenius System

  • Cardiac electrophysiology analysis system
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.4.0
In Commercial Distribution

  • 00860991000393 ()


  • Cardiology information system application software
ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data
EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
7.1
In Commercial Distribution

  • 00860991000386 ()


  • Cardiology information system application software
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