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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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EP-TRACER - 04260441452615

EP-TRACER 38 included in the cart system setup. The EP-TRACER system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
CardioTek B.V.
60SYS01
In Commercial Distribution

  • 04260441452615 ()


  • Cardiac electrophysiology analysis system

Adapter cables unipolar/ bipolar (set of 10) - 04260441450482

No Description
CardioTek B.V.
03UBC02
In Commercial Distribution

  • 04260441450482 ()


  • Cardiac electrophysiology analysis system

MLCL Upgrade - 00195278516015

Upgrade Kit MLCL V8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278516015 ()
5896597

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

MLCL Client Software - 00195278507525

Software Medical Device GE Client Software V8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507525 ()
5889605

  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

MUSE - 00195278458070

MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software

CAM - 00195278421449

CAM 14 - MDR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
14
In Commercial Distribution

  • 00195278421449 ()
900995-102

  • Electrocardiograph, professional, multichannel

CASE - 00195278403643

CASE V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V7.0
In Commercial Distribution

  • 00195278403643 ()
2035123-001

  • Electrocardiograph, professional, multichannel

CardioSoft - 00195278364661

CARDIOSOFT V7.0 SP7.2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V7.0
In Commercial Distribution

  • 00195278364661 ()
2006300-112

  • Electrocardiograph, professional, multichannel

iLab Ultrasound Imaging System - 08714729119593

Installed Basic System
BOSTON SCIENTIFIC CORPORATION
H749ILAB100INS0
In Commercial Distribution

  • 08714729119593 ()


  • Cardiovascular ultrasound imaging system

MLCL Upgrade - 00195278940193

Upgrade Kit MLCL V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278940193 ()
5973644

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system
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