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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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Pathfinder SL - 10841522124617

CD ASSY PATHFINDER SL 1.9
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522124617 ()
063-2468-00

  • Electrocardiographic long-term ambulatory recording analyser

Intesys® Clinical Suite - 10841522123580

SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
Smart Disclosure
In Commercial Distribution

  • 10841522123580 ()
92810

  • Medical equipment clinical data interfacing software

HearTwave II - 10841522123085

PM-3 PATIENT MODULE KIT,90200
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522123085 ()
707-0003-00

  • Cardiac stress exercise monitoring system

SPACELABS HEALTHCARE - 10841522121913

EP JUNCTION LEADSET,PM-3,US
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121913 ()
700-0356-01

  • Electrical-only medical device connection cable, reusable

SPACELABS HEALTHCARE - 10841522121845

PATIENT CABLE,STANDARD STRESS,PM-3,US
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121845 ()
700-0336-01

  • Electrocardiographic lead set, reusable

Spacelabs Healthcare - 10841522121753

MICRO-V ALTERNANS SENSOR(MV4),POUCH OF 7,UDI
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121753 ()
015-0721-01

  • Electrocardiographic electrode, single-use

Sentinal - 10841522128486

INSTALLATION KIT, SENTINEL 11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522128486 ()
040-5171-00

  • Cardiology information system application software

Spacelabs Healthcare - 10841522123832

HOLTER LEADWIRE, EVO/ARIA,WHITE. 1PK
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; TAY
Not in Commercial Distribution

  • 10841522123832 ()
700-0370-00

  • Electrocardiographic lead set, reusable

Intesys Clinical Suite - 10841522123597

CUSTOM TRENDS,92876
SPACELABS HEALTHCARE (WASHINGTON), INC
Smart Disclosure
In Commercial Distribution

  • 10841522123597 ()
92876

  • Medical equipment clinical data interfacing software

SPACELABS HEALTHCARE - 10841522121920

EP JUNCTION LEADSET,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121920 ()
700-0357-01

  • Electrical-only medical device connection cable, reusable
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