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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™ - 05414734211239

Display Workstation Kit
ST. JUDE MEDICAL, INC.
100026253
In Commercial Distribution

  • 05414734211239 ()
100026253

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210942

US Power Kit
ST. JUDE MEDICAL, INC.
100019043
In Commercial Distribution

  • 05414734210942 ()
100019043

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210881

RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421088
In Commercial Distribution

  • 05414734210881 ()
H421088

  • Electrical-only medical device connection cable, reusable
  • Cardiac mapping system

EnSite™ Velocity™ - 05414734210713

Amplifier
ST. JUDE MEDICAL, INC.
100014514
In Commercial Distribution

  • 05414734210713 ()
100014514

  • Cardiac mapping system

EnSite™ - 05414734210706

Module
ST. JUDE MEDICAL, INC.
Velocity ArrayLink
In Commercial Distribution

  • 05414734210706 ()
H421070

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05414734210690

RecordConnect Module Recording System Connector
ST. JUDE MEDICAL, INC.
H421069
In Commercial Distribution

  • 05414734210690 ()
H421069

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210614

Amplifier Kit
ST. JUDE MEDICAL, INC.
100012711
In Commercial Distribution

  • 05414734210614 ()
100012711

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210577

Amplifier Cart
ST. JUDE MEDICAL, INC.
Velocity System
In Commercial Distribution

  • 05414734210577 ()
100012183

  • Electromechanical device/system transport trolley

EnSite™ - 05414734210553

GenConnect Module Generator Connector
ST. JUDE MEDICAL, INC.
H421055
In Commercial Distribution

  • 05414734210553 ()
H421055

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210546

GenConnect Module Generator Connetor
ST. JUDE MEDICAL, INC.
H421054
In Commercial Distribution

  • 05414734210546 ()
H421054

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734210522

GenConnect Module Generator Connector
ST. JUDE MEDICAL, INC.
H421052
In Commercial Distribution

  • 05414734210522 ()
H421052

  • Electrical-only medical device connection adaptor, reusable

EnSite™ Velocity™ - 05414734210492

System RecordConnect Kit Universal
ST. JUDE MEDICAL, INC.
100010720
In Commercial Distribution

  • 05414734210492 ()
100010720

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05414734210256

Workstation Cart
ST. JUDE MEDICAL, INC.
Velocity System
In Commercial Distribution

  • 05414734210256 ()
100006217

  • Electromechanical device/system transport trolley

EnSite™ - 05414734210218

RecordConnect
ST. JUDE MEDICAL, INC.
System
In Commercial Distribution

  • 05414734210218 ()
H421021

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05414734210201

EP-WorkMate RecordConnect
ST. JUDE MEDICAL, INC.
Velocity
In Commercial Distribution

  • 05414734210201 ()
H421020

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05414734210195

RecordConnect
ST. JUDE MEDICAL, INC.
Velocity
In Commercial Distribution

  • 05414734210195 ()
H421019

  • Electrical-only medical device connection adaptor, reusable

EnSite™ - 05414734210188

Module
ST. JUDE MEDICAL, INC.
H421018
In Commercial Distribution

  • 05414734210188 ()
H421018

  • Electrical-only medical device connection adaptor, reusable

EnSite™ NavX™ - 05414734210003

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0010-100003331
In Commercial Distribution

  • 05414734210003 ()
  • 15414734210000 ()
EN0010-100003331

  • Cardiac mapping system reference patch

EnSite™ - 05414734209953

Module
ST. JUDE MEDICAL, INC.
Velocity NavLink
In Commercial Distribution

  • 05414734209953 ()
H420995

  • Electrical-only medical device connection adaptor, reusable

EP-NurseMate™ - 05414734207782

Physio Module
ST. JUDE MEDICAL, INC.
Station
In Commercial Distribution

  • 05414734207782 ()
NM-02

  • Cardiac catheterization monitoring system

EP-WorkMate™ - 05414734207546

Recording System
ST. JUDE MEDICAL, INC.
WM-01-1203
In Commercial Distribution

  • 05414734207546 ()
WM-01-1203

  • Cardiac catheterization monitoring system

EnSite™ - 05415067042507

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

  • 05415067042507 ()
ENSITE-AM-2.0

  • Cardiac mapping system application software

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™ - 05415067042460

EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-2.0
In Commercial Distribution

  • 05415067042460 ()
ENSITE-SW-2.0

  • Cardiac mapping system application software

WorkMate Claris™ - 05415067042385

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800014
In Commercial Distribution

  • 05415067042385 ()
H800014

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067042378

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800013
In Commercial Distribution

  • 05415067042378 ()
H800013

  • Cardiac catheterization monitoring system

WorkMate™ Scribe™ - 05415067042361

Software Upgrade Kit
ST. JUDE MEDICAL, INC.
H800015
In Commercial Distribution

  • 05415067042361 ()
H800015

  • Cardiac catheterization monitoring system

EnSite™ - 05415067041722

X EP System
ST. JUDE MEDICAL, INC.
ENSITE-SYSTEM-111
In Commercial Distribution

  • 05415067041722 ()
ENSITE-SYSTEM-111

  • Cardiac mapping system

EnSite Precision™ - 05415067041715

Surface Electrode Kit
ST. JUDE MEDICAL, INC.
EN0020-P
In Commercial Distribution

  • 15415067041712 ()
  • 05415067041715 ()
EN0020-P

  • Cardiac mapping system reference patch

EnSite™ - 05415067040770

X EP System Software Upgrade
ST. JUDE MEDICAL, INC.
ENSITE-SW-1.1.1
In Commercial Distribution

  • 05415067040770 ()
ENSITE-SW-1.1.1

  • Cardiac mapping system application software
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