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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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TactiCath™ Ablation Catheter, Sensor Enabled™ - 05415067029713

Catheter Catalog Installation
ST. JUDE MEDICAL, INC.
H702530
In Commercial Distribution

  • 05415067029713 ()
H702530

  • Cardiac mapping system application software

Advisor™ HD Grid Mapping Catheter - 05415067029256

Advisor HD Software Kit
ST. JUDE MEDICAL, INC.
H702519
In Commercial Distribution

  • 05415067029256 ()
H702519

  • Electrical-only medical device connection adaptor, reusable

Ensite™ - 05414734214841

No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214841 ()
75-06066-001

  • Cardiac mapping system application software

Ensite™ - 05414734214636

No Description
ST. JUDE MEDICAL, INC.
Fusion™ Module
In Commercial Distribution

  • 05414734214636 ()
75-05772-001

  • Cardiac mapping system application software

EnSite™ - 05414734214469

Ablation Cable Kit, IBI,T9
ST. JUDE MEDICAL, INC.
75-05392-001
In Commercial Distribution

  • 05414734214469 ()
75-05392-001

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734213738

Recorder Interconnect Kit, EPMED V5.0
ST. JUDE MEDICAL, INC.
75-04630-002
In Commercial Distribution

  • 05414734213738 ()
75-04630-002

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734213684

Ablation Cable Kit,Stockert
ST. JUDE MEDICAL, INC.
75-04469-003
In Commercial Distribution

  • 05414734213684 ()
75-04469-003

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734213660

Ablation Cable Kit, EPT
ST. JUDE MEDICAL, INC.
75-04467-004
In Commercial Distribution

  • 05414734213660 ()
75-04467-004

  • Electrical-only medical device connection cable, reusable

EnSite™ - 05414734211246

Amplifier Kit
ST. JUDE MEDICAL, INC.
100026488
In Commercial Distribution

  • 05414734211246 ()
100026488

  • Electrical-only medical device connection cable, reusable

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

NA - 05414734050241

Adapter Cable
ST. JUDE MEDICAL, INC.
12607
In Commercial Distribution

  • 05414734050241 ()
12607

  • Electrical-only medical device connection cable, reusable

EnSite™ Velocity™ - 05414734031035

Workstation
ST. JUDE MEDICAL, INC.
100026148
In Commercial Distribution

  • 05414734031035 ()
100026148

  • Cardiac mapping system

CardioInsight™ - 00643169723689

SENSOR ARRAY VEST CITVST0004XL US
MEDTRONIC, INC.
CITVST0004XL
In Commercial Distribution

  • 00643169723689 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723672

SENSOR ARRAY VEST CITVST0003L US
MEDTRONIC, INC.
CITVST0003L
In Commercial Distribution

  • 00643169723672 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723665

SENSOR ARRAY VEST CITVST0002M US
MEDTRONIC, INC.
CITVST0002M
Not in Commercial Distribution

  • 00643169723665 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723658

SENSOR ARRAY VEST CITVST0001S US
MEDTRONIC, INC.
CITVST0001S
In Commercial Distribution

  • 00643169723658 ()


  • Cardiac mapping system electrode array

CardioInsight™ - 00643169723603

MAPPING SYSTEM CIT200 CIT US
MEDTRONIC, INC.
CIT200
In Commercial Distribution

  • 00643169723603 ()


  • Cardiac mapping system

vMap Control Unit - 00860007954122

No Description
Vektor Medical, Inc.
VMCU2
In Commercial Distribution

  • 00860007954122 ()


  • Cardiac mapping system workstation

vMap Disposables - 00860007954115

No Description
Vektor Medical, Inc.
VMDISP2
In Commercial Distribution

  • 00860007954115 ()


  • Cardiac mapping system workstation

ECGenius System - 05745001034009

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 R3.2
In Commercial Distribution

  • 05745001034009 ()
CVT-0069 R3.2 ECGenius System

  • Cardiac electrophysiology analysis system
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