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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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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

Xper Information Management System - 00884838070721

No Description
Philips Medical Systems Nederland B.V.
2.1
In Commercial Distribution

  • 00884838070721 ()
453564530681

  • Patient health record information system

Xper Information Management System - 00884838070691

No Description
Philips Medical Systems Nederland B.V.
1.5
In Commercial Distribution

  • 00884838070691 ()
453564495001

  • Patient health record information system
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