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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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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

EnSite™ Velocity™ - 05415067008718

Workstation Accessory Kit
ST. JUDE MEDICAL, INC.
100045484
In Commercial Distribution

  • 05415067008718 ()
100045484

  • Electrical-only medical device connection cable, reusable

MediGuide™ - 05415067006752

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006752 ()
H700675

  • Cardiac mapping system

MediGuide™ - 05415067006721

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006721 ()
H700672

  • Cardiac mapping system

MediGuide™ - 05415067006714

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006714 ()
H700671

  • Cardiac mapping system

MediGuide™ - 05415067006707

MTAC
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006707 ()
H700670

  • Cardiac mapping system

MediGuide™ - 05415067006691

TSU
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006691 ()
H700669

  • Cardiac mapping system

MediGuide™ - 05415067006684

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067006684 ()
H700668

  • Cardiac mapping system

EnSite™ - 05415067005861

Kit
ST. JUDE MEDICAL, INC.
Derexi™
In Commercial Distribution

  • 05415067005861 ()
H700586

  • Cardiac mapping system application software

MediGuide™ - 05415067004697

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004697 ()
H700469

  • Cardiac mapping system

MediGuide™ - 05415067004680

Connect
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004680 ()
H700468

  • Cardiac mapping system

MediGuide™ - 05415067004604

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004604 ()
H700460

  • Cardiac mapping system

MediGuide™ - 05415067004314

Magnetic Transmitter Assembly
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004314 ()
H700431

  • Cardiac mapping system

MediGuide™ - 05415067004307

No Description
ST. JUDE MEDICAL, INC.
Technology
In Commercial Distribution

  • 05415067004307 ()
H700430

  • Cardiac mapping system

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™ - 05415067001610

IBP Cable, For Use With Utah Medical Deltran™ II
ST. JUDE MEDICAL, INC.
H700161
In Commercial Distribution

  • 05415067001610 ()
H700161

  • 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™ - 05415067001580

IBP Cable, For Use With Navilyst Medical Namic™ Perceptor™ DT
ST. JUDE MEDICAL, INC.
H700158
In Commercial Distribution

  • 05415067001580 ()
H700158

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001573

IBP Cable, For Use With Merit Medical Meritrans™
ST. JUDE MEDICAL, INC.
H700157
In Commercial Distribution

  • 05415067001573 ()
H700157

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001566

IBP Cable, For Use With Smiths Medical LogiCal™ MX960
ST. JUDE MEDICAL, INC.
H700156
In Commercial Distribution

  • 05415067001566 ()
H700156

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001559

IBP Cable, For Use With Smiths Medical TranStar™ MX950
ST. JUDE MEDICAL, INC.
H700155
In Commercial Distribution

  • 05415067001559 ()
H700155

  • Cardiac catheterization monitoring system

WorkMate Claris™ - 05415067001542

IBP Cable, For Use With Smiths Medical NovaTrans II™ MX860
ST. JUDE MEDICAL, INC.
H700154
In Commercial Distribution

  • 05415067001542 ()
H700154

  • Cardiac catheterization monitoring system
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