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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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Ablamap® System - 00860457001568

The Ablamap® System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and workstation that contains proprietary mapping software. Signals are transmitted from a 64-electrode mapping “basket” catheter, through the amplifier, to the workstation, processed by the mapping software, and the results are displayed on the monitor.
Ablacon Inc.
AB-0007
In Commercial Distribution

  • 00860457001568 ()


  • Cardiac mapping system computer

vMap Control Unit - 00860007954177

No Description
Vektor Medical, Inc.
VMCU1
In Commercial Distribution

  • 00860007954177 ()


  • Cardiac mapping system computer

vMap Disposables - 00860007954108

No Description
Vektor Medical, Inc.
VMDISP1
In Commercial Distribution

  • 00860007954108 ()


  • Cardiac mapping system computer

VISITAG EXT PROCESSING UNIT ACCESS - 10846835018585

DOCK, VISITAG SURPOINT EPU SP
Biosense Webster Inc
M665701SP
In Commercial Distribution

  • 10846835018585 ()
M665701SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU SPARE - 10846835018578

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660201SP
In Commercial Distribution

  • 10846835018578 ()
M660201SP

  • Cardiac mapping system computer

VISITAG SURPOINT EPU - 10846835018554

EXT PROCESSING UNIT ACCESSORIE
Biosense Webster Inc
M660202SP
In Commercial Distribution

  • 10846835018554 ()
M660202SP

  • Cardiac mapping system computer

VISITAG SURPOINT External Processing Unit - 10846835017885

External Processing Unit
Biosense Webster Inc
D160801
In Commercial Distribution

  • 10846835017885 ()
D160801

  • Cardiac mapping system computer

ACIST RXi® Console with dPR - 10841716103763

RXi Console with dPR, US (p/n: 800939-010 )
ACIST MEDICAL SYSTEMS, INC.
019994
In Commercial Distribution

  • 10841716103763 ()
  • 30841716103767 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Navvus Interface - 10841716101790

RXi Mini Navvus Interface p/n 701600-002
ACIST MEDICAL SYSTEMS, INC.
018592
In Commercial Distribution

  • 30841716101794 ()
  • 10841716101790 ()


  • Cardiac catheterization laboratory computer

ACIST RXi® Mini Processing Unit - 10841716101783

RXi Mini Processing Unit p/n 701630-002
ACIST MEDICAL SYSTEMS, INC.
018593
In Commercial Distribution

  • 30841716101787 ()
  • 10841716101783 ()


  • Cardiac catheterization laboratory computer
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