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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™ - 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

EnSite™ - 05415067050021

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

EnSite™ - 05415067050014

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

EnSite™ - 05415067049988

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

EnSite™ - 05415067049711

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

EnSite™ - 05415067049704

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

EnSite™ - 05415067048721

X Amplifier Air Filter
ST. JUDE MEDICAL, INC.
ENSITE-AAF-01
In Commercial Distribution

  • 05415067048721 ()
ENSITE-AAF-01

  • Cardiac mapping system

EnSite™ - 05415067048400

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

EnSite™ - 05415067048394

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

EnSite™ - 05415067048387

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

EnSite™ - 05415067048370

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

EnSite™ - 05415067048363

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

EnSite™ - 05415067048356

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

EnSite™ - 05415067048349

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

EnSite™ - 05415067048332

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

EnSite™ - 05415067047861

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

EnSite™ - 05415067047854

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-03
In Commercial Distribution

  • 05415067047854 ()
ENSITE-SW-03

  • Cardiac mapping system application software

WorkMate™ Unity™ - 05415067047229

Software Upgrade, 10 Licenses
ST. JUDE MEDICAL, INC.
H800020
In Commercial Distribution

  • 05415067047229 ()
H800020

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067047212

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800022
In Commercial Distribution

  • 05415067047212 ()
H800022

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067047205

Module Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800018
In Commercial Distribution

  • 05415067047205 ()
H800018

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067047199

Software Upgrade Site License
ST. JUDE MEDICAL, INC.
H800021
In Commercial Distribution

  • 05415067047199 ()
H800021

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067047182

Z620 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800016
In Commercial Distribution

  • 05415067047182 ()
H800016

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067047175

Z440 Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800017
In Commercial Distribution

  • 05415067047175 ()
H800017

  • Cardiac catheterization monitoring system

WorkMate™ Unity™ - 05415067047168

Module Software Upgrade Single License
ST. JUDE MEDICAL, INC.
H800019
In Commercial Distribution

  • 05415067047168 ()
H800019

  • Cardiac catheterization monitoring system

EnSite Precision™ - 05415067046802

Software Upgrade
ST. JUDE MEDICAL, INC.
H704002
In Commercial Distribution

  • 05415067046802 ()
H704002

  • Cardiac mapping system application software

EnSite™ - 05415067046710

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-2.0.1
In Commercial Distribution

  • 05415067046710 ()
ENSITE-DWS-2.0.1

  • Cardiac mapping system

EnSite™ - 05415067046703

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

EnSite™ - 05415067046697

X EP System EnSite Cloud Software License
ST. JUDE MEDICAL, INC.
ENSITE-CL-01
In Commercial Distribution

  • 05415067046697 ()
ENSITE-CL-01

  • Cardiac mapping system

EnSite™ - 05415067046680

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-2.0.1
In Commercial Distribution

  • 05415067046680 ()
ENSITE-R-DWS-2.0.1

  • Cardiac mapping system

EnSite™ - 05415067046673

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

EnSite™ - 05415067046666

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-201
In Commercial Distribution

  • 05415067046666 ()
ENSITE-SYSTEM-201

  • Cardiac mapping system

EnSite™ - 05415067046659

X EP System TactiFlex Ablation Catheter, SE Software License
ST. JUDE MEDICAL, INC.
ENSITE-TF-02
In Commercial Distribution

  • 05415067046659 ()
ENSITE-TF-02

  • Cardiac mapping system application software

EnSite™ - 05415067046642

X EP System OTA Certificate Software License
ST. JUDE MEDICAL, INC.
ENSITE-OTAC-01
In Commercial Distribution

  • 05415067046642 ()
ENSITE-OTAC-01

  • Cardiac mapping system application software

EnSite™ - 05414734219228

Cable
ST. JUDE MEDICAL, INC.
H21922
In Commercial Distribution

  • 05414734219228 ()
H21922

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734219211

Software Upgrade Kitv.3.0.1.1
ST. JUDE MEDICAL, INC.
H21921
In Commercial Distribution

  • 05414734219211 ()
H21921

  • Cardiac mapping system application software

EP-WorkMate™ - 05414734219105

No Description
ST. JUDE MEDICAL, INC.
Recording System
In Commercial Distribution

  • 05414734219105 ()
H21910

  • Cardiac catheterization monitoring system

WorkMate™ - 05415067010605

Display Workstation
ST. JUDE MEDICAL, INC.
H701060
In Commercial Distribution

  • 05415067010605 ()
H701060

  • Cardiac catheterization monitoring system

MediGuide™ - 05415067009807

Power Supply
ST. JUDE MEDICAL, INC.
H700980
In Commercial Distribution

  • 05415067009807 ()
H700980

  • Cardiac mapping system

MediGuide™ - 05415067009791

Power Supply
ST. JUDE MEDICAL, INC.
H700979
In Commercial Distribution

  • 05415067009791 ()
H700979

  • Cardiac mapping system

WorkMate Claris™ - 05415067009777

Display Workstation
ST. JUDE MEDICAL, INC.
H700977
In Commercial Distribution

  • 05415067009777 ()
H700977

  • Cardiac catheterization monitoring system
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