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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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INW Server - 00840682123563

SOFTWARE INW SERVER V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123563 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

Mac-Lab - 00840682123556

SOFTWARE MAC-LAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123556 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682123549

SOFTWARE CARDIOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123549 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

GE Client Software - 00840682123532

SOFTWARE GE CLIENT SOFTWARE V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123532 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

CardioLab - 00840682119689

ASSY, CARDIOLAB SIMULATOR GE INT USE
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator-Internal
Not in Commercial Distribution

  • 00840682119689 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

PDM Base Station - 00840682119665

ASSY PDM BASE STATION PLUS CO2
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Plus
In Commercial Distribution

  • 00840682119665 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

CardioLab - 00840682119641

ASSY, CARDIOLAB SIMULATOR
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Simulator
Not in Commercial Distribution

  • 00840682119641 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

Rhythmia HDx™ Mapping System - 00191506000813

Location Reference Patch Kit
BOSTON SCIENTIFIC CORPORATION
M004RAPATCH20
In Commercial Distribution

  • 00191506000813 ()
M004RAPATCH20

  • Cardiac mapping system reference patch

OPAL HDx™ - 00191506055370

Mapping System
BOSTON SCIENTIFIC CORPORATION
M004OPLINSTALL2EN0
In Commercial Distribution

  • 00191506055370 ()
M004OPLINSTALL2EN0

  • Cardiac mapping system

OPAL HDx™ - 00191506055325

Mapping System Signal Station
BOSTON SCIENTIFIC CORPORATION
M004OPAL10200
In Commercial Distribution

  • 00191506055325 ()
M004OPAL10200

  • Cardiac mapping system
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