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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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MLCL Upgrade - 00195278940193

Upgrade Kit MLCL V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278940193 ()
5973644

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

MLCL Client Software - 00195278931504

Software Medical Device GE Client Software V9.0
Ge Medical Systems Information Technologies, Inc.
AltiX AI.i
In Commercial Distribution

  • 00195278931504 ()
5973597

  • Cardiac electrophysiology analysis system
  • Cardiac catheterization monitoring system

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

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
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