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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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CUFF,ABP,ADULT,XL,38-50CM/15-20IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129629 ()

  • 38-50 cm OD
  • 15-20 in OD
016-0109-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,L,32-42CM/13-17IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129612 ()

  • 32-42 cm OD
  • 13-17 in OD
016-0077-07Q

  • Blood pressure ambulatory recorder
CUFF,ABP,CHILD,12-20CM/5-8IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129605 ()

  • 12-20 cm OD
  • 5-8 in. OD
015-0118-06Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT M,24-32CM/9-13IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129599 ()
015-0068-07Q

  • Blood pressure ambulatory recorder
CUFF,ABP,ADULT,S,17-26CM/7-10IN,NO LTX
SPACELABS HEALTHCARE (WASHINGTON), INC
ABP Cuffs and Cuff Covers
In Commercial Distribution

  • 10841522129582 ()

  • 17-26 cm OD
  • 7-10 in. OD
015-0067-06Q

  • Blood pressure ambulatory recorder
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 ANALYSER
SPACELABS HEALTHCARE (WASHINGTON), INC
Pathfinder SL
In Commercial Distribution

  • 10841522129537 ()
98000SL

  • Electrocardiographic long-term ambulatory recording analyser
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 11 RDT TEST SYSTEM
SPACELABS HEALTHCARE (WASHINGTON), INC
Sentinal 11
In Commercial Distribution

  • 10841522129414 ()
040-1725-01

  • Cardiology information system application software
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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