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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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Merge Hemo - 00842000100874

No Description
MERGE HEALTHCARE SOLUTIONS INC.
10.3
In Commercial Distribution

  • 00842000100874 ()


  • Patient monitoring system module, multifunction

MLCL Client Software - 00195278507525

Software Medical Device GE Client Software V8.0
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
AltiX
In Commercial Distribution

  • 00195278507525 ()
5889605

  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

MUSE - 00195278458070

MUSE NX R2 SOFTWARE
Ge Medical Systems Information Technologies, Inc.
NX R2
In Commercial Distribution

  • 00195278458070 ()
4101010-002

  • Cardiology information system application software

CAM - 00195278421449

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

  • 00195278421449 ()
900995-102

  • Electrocardiograph, professional, multichannel

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
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