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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LIFESCREEN PRO ANALYSER, V1.X
SPACELABS HEALTHCARE (WASHINGTON), INC
Lifescreen Pro
In Commercial Distribution

  • 10841522128837 ()
98800

  • Electrocardiographic long-term ambulatory recording analyser
INSTALLATION KIT, PATHFINDER SL 1.9.2
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522128820 ()
040-1763-00

  • Electrocardiographic long-term ambulatory recording analyser
INSTALLATION KIT, SENTINEL 11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522128486 ()
040-5171-00

  • Cardiology information system application software
PATHFINDER SL HOLTER ANALYSIS SYSTEM (ENGLISH)
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522126000 ()
98000-01

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125904 ()
040-1756-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125898 ()
040-1755-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT NL  
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125881 ()
040-1754-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125874 ()
040-1753-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125867 ()
040-1752-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125850 ()
040-1751-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125843 ()
040-1750-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 11 / PATHFINDER SL KIT IT  
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125836 ()
040-1749-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125829 ()
040-1748-01

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
PATHFINDER SL/SENTINEL 11 EVAL SYSTEM (ENG)
SPACELABS HEALTHCARE (WASHINGTON), INC
98000; 98200
In Commercial Distribution

  • 10841522125812 ()
040-1726-02

  • Electrocardiographic long-term ambulatory recording analyser
  • Cardiology information system application software
SENTINEL 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522125805 ()
040-1725-01

  • Cardiology information system application software
SENTINEL 11 HL7 TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522125799 ()
040-1724-01

  • Cardiology information system application software
SENTINEL 11 NETWORKED TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522125782 ()
040-1723-01

  • Cardiology information system application software
SENTINEL 11 STANDALNE TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
98200
In Commercial Distribution

  • 10841522125775 ()
040-1722-01

  • Cardiology information system application software
SENTINEL 11 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98200; 98000
In Commercial Distribution

  • 10841522125768 ()
040-1708-01

  • Cardiology information system application software
  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL SOFTWARE V11
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinel 11
In Commercial Distribution

  • 10841522125751 ()
98201

  • Cardiology information system application software
SENTINEL 10 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
In Commercial Distribution

  • 10841522125737 ()
040-1756-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125720 ()
040-1755-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125713 ()
040-1754-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125706 ()
040-1753-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125690 ()
040-1752-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
In Commercial Distribution

  • 10841522125683 ()
040-1751-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125676 ()
040-1750-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125669 ()
040-1749-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125652 ()
040-1748-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT EN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125638 ()
040-1708-00

  • Electrocardiographic long-term ambulatory recording analyser
PATHFINDER SL KIT CN
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522125102 ()
040-1757-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT DE
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125096 ()
040-1756-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT DN
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125089 ()
040-1755-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT NL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125072 ()
040-1754-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT BR-PT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125065 ()
040-1753-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT PL
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125058 ()
040-1752-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT SV
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125041 ()
040-1751-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT ES
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125034 ()
040-1750-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT IT
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125027 ()
040-1749-00

  • Electrocardiographic long-term ambulatory recording analyser
SENTINEL 10 / PATHFINDER SL KIT FR
SPACELABS HEALTHCARE (WASHINGTON), INC
98000
Not in Commercial Distribution

  • 10841522125010 ()
040-1748-00

  • Electrocardiographic long-term ambulatory recording analyser
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
HOLTER LEADWIRE, EVO/ARIA,WHITE. 1PK
SPACELABS HEALTHCARE (WASHINGTON), INC
ARIA; TAY
Not in Commercial Distribution

  • 10841522123832 ()
700-0370-00

  • Electrocardiographic lead set, reusable
CUSTOM TRENDS,92876
SPACELABS HEALTHCARE (WASHINGTON), INC
Smart Disclosure
In Commercial Distribution

  • 10841522123597 ()
92876

  • Medical equipment clinical data interfacing software
SMART DISCLOSURE,92810
SPACELABS HEALTHCARE (WASHINGTON), INC
Smart Disclosure
In Commercial Distribution

  • 10841522123580 ()
92810

  • Medical equipment clinical data interfacing software
PM-3 PATIENT MODULE KIT,90200
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522123085 ()
707-0003-00

  • Cardiac stress exercise monitoring system
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
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
PATIENT CABLE,STANDARD STRESS,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121869 ()
700-0338-01

  • Electrical-only medical device connection cable, reusable
PATIENT CABLE,MICRO-V,PM-3,EU
SPACELABS HEALTHCARE (WASHINGTON), INC
90200
Not in Commercial Distribution

  • 10841522121852 ()
700-0334-01

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

  • 10841522121845 ()
700-0336-01

  • Electrocardiographic lead set, reusable
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