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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 - 04260441455418

EP-TRACER 38 included in the portable 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.
40SYS01
In Commercial Distribution

  • 04260441455418 ()


  • Cardiac electrophysiology analysis system

EP-TRACER - 04260441455326

EP-TRACER 70 included in the stationary 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.
32SYS02
In Commercial Distribution

  • 04260441455326 ()


  • Cardiac electrophysiology analysis system

Merge Hemo - 00842000101079

No Description
MERGE HEALTHCARE SOLUTIONS INC.
RCSV2
In Commercial Distribution

  • 00842000101079 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100966

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.4
In Commercial Distribution

  • 00842000100966 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100874

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100874 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100430

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.2
In Commercial Distribution

  • 00842000100430 ()


  • Patient monitoring system module, multifunction

Merge Hemo - 00842000100027

No Description
MERGE HEALTHCARE SOLUTIONS INC.
9.4
In Commercial Distribution

  • 00842000100027 ()


  • Patient monitoring system module, multifunction

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

MLCL Client Software - 00195278931504

Software Medical Device GE Client Software V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278931504 ()
5973597

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring 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
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