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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

GEMS Win HL7 - 00812324000266

HL7 plug-in module for GEMS Win
CardioComm Solutions, Inc
GW-HL7
In Commercial Distribution

  • 00812324000266 ()
GW-HL7

  • Cardiac mapping system computer

GEMS Win Air - 00812324000259

GEMS Win Air
CardioComm Solutions, Inc
GW-AIR
In Commercial Distribution

  • 00812324000259 ()
GW-AIR

  • Cardiac mapping system computer

GEMS Win AutoAttendant - 00812324000242

GEMS Win AutoAttendant
CardioComm Solutions, Inc
GW-AA
In Commercial Distribution

  • 00812324000242 ()
GW-AA

  • Cardiac mapping system computer

GEMS Win TTM & ICD - 00812324000228

GEMS Win ARR TTM & Full Pacing
CardioComm Solutions, Inc
GW-TTMICD
In Commercial Distribution

  • 00812324000228 ()
GW-TTMICD

  • Cardiac mapping system computer

GEMS Win TTM - 00812324000211

Global ECG Management System for Windows with Arrhythmia and TTM
CardioComm Solutions, Inc
GW-TTM
In Commercial Distribution

  • 00812324000211 ()
GW-TTM

  • Cardiac mapping system computer

GEMS Win Arrhythmia - 00812324000204

Global ECG Management System (GEMS) for Windows Arrhythmia
CardioComm Solutions, Inc
GW-ARR
In Commercial Distribution

  • 00812324000204 ()
GW-ARR

  • Cardiac mapping system computer

TactiSys™ - 07640157990316

Display Workstation
ST. JUDE MEDICAL, INC.
PN-004711
In Commercial Distribution

  • 07640157990316 ()
PN-004711

  • Cardiac mapping system computer

TactiSys™ - 07640157990194

Quartz Equipment
ST. JUDE MEDICAL, INC.
PN-004400
In Commercial Distribution

  • 07640157990194 ()
PN-004400

  • Cardiac mapping system computer

Sensis Vibe Combo - 04056869010205

Device originally cleared as "Sensis"; Name change to "Sensis Vibe Combo" described in NFJ filed on 2016-03-22
Siemens Healthcare GmbH
11007642
In Commercial Distribution

  • 04056869010205 ()


  • Cardiac catheterization laboratory computer
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