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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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CARTO 3 - 10846835000870

CARTO 3 System
BIOSENSE WEBSTER (ISRAEL) LTD.
FG540000
In Commercial Distribution

  • 10846835000870 ()
FG-5400-00

  • Cardiac mapping system

CAM - 00840682110075

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

  • 00840682110075 ()


  • Electrocardiograph, professional, single-channel

CV Web - 00840682107921

CV WEB 3.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
3
Not in Commercial Distribution

  • 00840682107921 ()


  • Cardiology information system application software

NA - 00840682104104

No Description
GE Healthcare Finland Oy
E-COP-01
In Commercial Distribution

  • 00840682104104 ()


  • Patient monitoring system module, multifunction

NA - 00840682104098

No Description
GE Healthcare Finland Oy
E-COPSv-01
In Commercial Distribution

  • 00840682104098 ()


  • Patient monitoring system module, multifunction

CAM-USB - 00840682109772

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE V2
In Commercial Distribution

  • 00840682109772 ()


  • Cardiac stress exercise monitoring system

CAM-USB - 00840682109611

No Description
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
INTERFACE A/T V2
In Commercial Distribution

  • 00840682109611 ()


  • Cardiac stress exercise monitoring system

CardioSoft - 00840682105170

CARDIOSOFT V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
In Commercial Distribution

  • 00840682105170 ()


  • Electrocardiograph, professional, multichannel

CS - 00840682105156

CS V6.73
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.73
Not in Commercial Distribution

  • 00840682105156 ()


  • Electrocardiograph, professional, multichannel

CASE - 00840682105088

CASE V6.7
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V6.7
In Commercial Distribution

  • 00840682105088 ()


  • Electrocardiograph, professional, multichannel

MUSE - 00840682100182

MUSE V9
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v9
In Commercial Distribution

  • 00840682100182 ()


  • Cardiology information system application software

MARS - 00840682100069

MARS V8
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
V8
Not in Commercial Distribution

  • 00840682100069 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

Graffiti - 00840682152754

MD ACUTE VIRTUAL COLLABORATOR NOTIFY ME 1.0
GE HEALTHCARE
NotifyMe V1.0
Not in Commercial Distribution

  • 00840682152754 ()


  • Patient health record information system

GE Client Software - 00840682145763

Software Medical Device GE Client Software V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145763 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

INW Server - 00840682145756

Software Medical Device INW V7.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
A1
Not in Commercial Distribution

  • 00840682145756 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

MUSE - 00840682142809

MUSE NX
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
NX
In Commercial Distribution

  • 00840682142809 ()


  • Cardiology information system application software

MLCL Upgrade - 00840682188968

Upgrade Kit MLCL V7.1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
BT21
Not in Commercial Distribution

  • 00840682188968 ()


  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

GE Client Workstation - 00840682123594

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

  • 00840682123594 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

SpecialsLab - 00840682123587

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

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

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

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

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

OPAL HDx™ - 00191506055301

Mapping System Workstation PC
BOSTON SCIENTIFIC CORPORATION
M004OPAL40100
In Commercial Distribution

  • 00191506055301 ()
M004OPAL40100

  • Cardiac mapping system

Guidewire - 00841268100541

Guidewire
GALT MEDICAL CORP.
SGW-011-08
In Commercial Distribution

  • 00841268100541 ()
  • 10841268100548 ()
  • 20841268100545 ()

  • Outer Diameter: 0.035 Inch
SGW-011-08

  • Peripheral vascular guidewire, manual

CASE - 00195278617644

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

  • 00195278617644 ()
3031234-001

  • Electrocardiograph, professional, multichannel

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

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

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

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
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