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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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ASSY CLABII PLUS64 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
64 Channel
Not in Commercial Distribution

  • 00840682119634 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
128 Channel
In Commercial Distribution

  • 00840682119603 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522125645 ()
040-1726-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 10.0.1 STANDALONE WORKSTAT LICENCE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123269 ()
040-1702-00

  • Cardiology information system application software
SENTINEL 10.0.1 OFFLINE/NETWORK WORKSTAT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123252 ()
040-1705-00

  • Cardiology information system application software
SENTINEL 10.0.1 NETWORK WORKSTATION LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123245 ()
040-1703-00

  • Cardiology information system application software
PATHFINDER SL/SENTINEL 10 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000, 98200
Not in Commercial Distribution

  • 10841522124563 ()
040-1726-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10.0.1 ADD. NETWORK WORKSTAT LICENSE EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123238 ()
040-1704-00

  • Cardiology information system application software
SENTINEL 10 WORKSTATION (X1) + 4 WEB LICENSES
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
Not in Commercial Distribution

  • 10841522123221 ()
040-1713-00

  • Cardiology information system application software
Main Unit;
CNSystems Medizintechnik GmbH
V1.5
In Commercial Distribution

  • 09120073933027 ()
21-FHCN-15544

  • Patient monitoring system module, blood pressure, noninvasive
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