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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 - 10846835003826

No Description
Biosense Webster Inc
CG2025CT
In Commercial Distribution

  • 10846835003826 ()
CG2025CT

  • Electrical-only medical device connection cable, reusable

Carto 3 - 10846835003802

No Description
Biosense Webster Inc
CB3434CT
In Commercial Distribution

  • 10846835003802 ()
CB3434CT

  • Electrical-only medical device connection cable, reusable

Carto 3 - 10846835003796

No Description
Biosense Webster Inc
CB3412CT
In Commercial Distribution

  • 10846835003796 ()
CB3412CT

  • Electrical-only medical device connection cable, reusable

Carto 3 - 10846835003789

No Description
Biosense Webster Inc
CB3410CT
In Commercial Distribution

  • 10846835003789 ()
CB3410CT

  • Electrical-only medical device connection cable, reusable

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

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

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

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

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

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

SENTINEL - 10841522130922

SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522130922 ()
040-1724-01

  • Cardiology information system application software

Lifescreen Pro - 10841522129773

SENTINEL/LIFESCREEN PRO RAPID ANALYSIS KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522129773 ()
040-5173-00

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

Sentinel - 10841522129551

UPGRADE, SENTINEL 10.5 TO 11.5 OR HIGHER
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129551 ()
040-1766-00

  • Cardiology information system application software

Holter Prep Kit - 10812345029939

Holter prep kit with AA battery cleared with Vision 5LR recorder
MORTARA INSTRUMENT, INC.
043272
In Commercial Distribution

  • 10812345029939 ()
  • 20812345029936 ()
  • 30812345029933 ()


  • Electrocardiographic ambulatory recorder

CER-S - B972CCZ12050482080

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482080 ()
CCZ1205048208

  • Electrocardiographic long-term ambulatory recording analyser application software

CER-S - B972CCZ12050482050

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482050 ()
CCZ1205048205

  • Electrocardiographic long-term ambulatory recording analyser application software

CER-S - B972CCZ12050482030

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.
CARDIO CALM SRL
4
In Commercial Distribution

  • B972CCZ12050482030 ()


  • Electrocardiographic long-term ambulatory recording analyser application software

ILR ECG Analyzer - 03770025266008

No Description
Implicity Inc.
V1.1.4
In Commercial Distribution

  • 03770025266008 ()
IM007

  • Cardiology information system application software

Pathfinder SL - 10841522129537

PATHFINDER SL ANALYSER
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522129537 ()
98000SL

  • Electrocardiographic long-term ambulatory recording analyser

Sentinal - 10841522129506

SENTINEL V11.X UPGRADE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129506 ()
040-5172-00

  • Cardiology information system application software

Sentinal - 10841522129438

SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129438 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

SENTINEL - 10841522129414

SENTINEL 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129414 ()
040-1725-01

  • Cardiology information system application software

Sentinel - 10841522129407

SENTINEL 11 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129407 ()
040-1756-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software

Sentinel - 10841522129391

SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
Not in Commercial Distribution

  • 10841522129391 ()
040-1755-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser

SENTINEL - 10841522129384

SENTINEL 11 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
Not in Commercial Distribution

  • 10841522129384 ()
040-1754-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
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