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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™ - 05415067003867

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H700386
In Commercial Distribution

  • 05415067003867 ()
H700386

  • Cardiac mapping system

EP-WorkMate™ - 05415067003560

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

  • 05415067003560 ()
100043247

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067003553

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
100041650
In Commercial Distribution

  • 05415067003553 ()
100041650

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067003461

No Description
ST. JUDE MEDICAL, INC.
09-0080-0000
In Commercial Distribution

  • 05415067003461 ()
09-0080-0000

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067003126

56 Channel SCU
ST. JUDE MEDICAL, INC.
100019209
In Commercial Distribution

  • 05415067003126 ()
100019209

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05415067003119

120 Channel SCU
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05415067003119 ()
09-1463-0120

  • Cardiac catheterization monitoring system

EnSite™ - 05415067003041

DWS Kit
ST. JUDE MEDICAL, INC.
Velocity System
In Commercial Distribution

  • 05415067003041 ()
100027825

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05415067003027

Software Installation
ST. JUDE MEDICAL, INC.
100037184
In Commercial Distribution

  • 05415067003027 ()
100037184

  • Cardiac mapping system application software

EnSite™ - 05415067002952

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700295
In Commercial Distribution

  • 05415067002952 ()
H700295

  • Cardiac mapping system application software

EnSite™ - 05415067002938

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700293
In Commercial Distribution

  • 05415067002938 ()
H700293

  • Cardiac mapping system application software

EnSite™ - 05415067002921

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H700292
In Commercial Distribution

  • 05415067002921 ()
H700292

  • Cardiac mapping system application software

EnSite™ - 05415067001863

Software Installation
ST. JUDE MEDICAL, INC.
H700186
In Commercial Distribution

  • 05415067001863 ()
H700186

  • Cardiac mapping system application software

EnSite™ - 05415067001856

Software Upgrade Kit v.3.1
ST. JUDE MEDICAL, INC.
H700185
In Commercial Distribution

  • 05415067001856 ()
H700185

  • Cardiac mapping system application software

N/A - 05415067001825

Power Cord
ST. JUDE MEDICAL, INC.
H700182
In Commercial Distribution

  • 05415067001825 ()
H700182

  • Electrical-only medical device connection cable, reusable

WorkMate Claris™ - 05415067001696

Amplifier
ST. JUDE MEDICAL, INC.
H700169
In Commercial Distribution

  • 05415067001696 ()
H700169

  • Cardiac catheterization monitoring system

WorkMate™ - 05415067001634

Generic Stimulator Cable
ST. JUDE MEDICAL, INC.
H700163
In Commercial Distribution

  • 05415067001634 ()
H700163

  • Cardiac catheterization monitoring system

EP-4™ - 05415067001627

Cardiac Stimulator Cardiac Stimulator Cable
ST. JUDE MEDICAL, INC.
H700162
In Commercial Distribution

  • 05415067001627 ()
H700162

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001597

IBP Cable, For Use With Argon DTXPlus™
ST. JUDE MEDICAL, INC.
H700159
In Commercial Distribution

  • 05415067001597 ()
H700159

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001535

IBP Cable, For Use With Argon ArgoTrans Model 1
ST. JUDE MEDICAL, INC.
H700153
In Commercial Distribution

  • 05415067001535 ()
H700153

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001528

IBP Cable, For Use With Edwards Lifesciences TruWave
ST. JUDE MEDICAL, INC.
H700152
In Commercial Distribution

  • 05415067001528 ()
H700152

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001504

Display Plus Amplifier
ST. JUDE MEDICAL, INC.
H700150
In Commercial Distribution

  • 05415067001504 ()
H700150

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001337

ECG Cable Set, Radiolucent
ST. JUDE MEDICAL, INC.
H700133
In Commercial Distribution

  • 05415067001337 ()
H700133

  • Cardiac catheterization monitoring system

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™ - 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™ - 05415067053121

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

EnSite™ - 05415067051165

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-3.1
In Commercial Distribution

  • 05415067051165 ()
ENSITE-SYSTEM-3.1

  • Cardiac mapping system

EnSite™ - 05415067051141

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-R-DWS-3.1
In Commercial Distribution

  • 05415067051141 ()
ENSITE-R-DWS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051134

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-R-SYS-3.1
In Commercial Distribution

  • 05415067051134 ()
ENSITE-R-SYS-3.1

  • Cardiac mapping system

EnSite™ - 05415067051127

X EP System Display Workstation
ST. JUDE MEDICAL, INC.
ENSITE-DWS-3.1
In Commercial Distribution

  • 05415067051127 ()
ENSITE-DWS-3.1

  • Cardiac mapping system

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™ - 05415067051103

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

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™ - 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

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™ - 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
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