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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DreamStation BiPAP AVAPS 30, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM, CA
In Commercial Distribution

  • 00606959040908 ()
CAX1130S12

  • Portable electric ventilator
PRI Cellular Modem, Australia, Canada
Respironics, Inc.
PRI Cellular Modem, AU, CA
In Commercial Distribution

  • 00606959040403 ()
100215C

  • Clinical laboratory information system
Dorma 200 with Humidifier, Canada
Respironics, Inc.
Dorma 200 with Humidifier, CA
In Commercial Distribution

  • 00606959038585 ()
CAV201H

  • Home CPAP unit
  • Heated respiratory humidifier
REMstar Pro, with BlueTooth, Canada
Respironics, Inc.
REMstar Pro w/BlueTooth, CA
In Commercial Distribution

  • 00606959030169 ()
461CABT

  • Home CPAP unit
REMstar Plus, System One 60 Series, Canada
Respironics, Inc.
REMstar Plus, 60 Series, CA
In Commercial Distribution

  • 00606959030053 ()
CA261S

  • Home CPAP unit
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407509
In Commercial Distribution

  • 00195226000818 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415009
In Commercial Distribution

  • 00195226000801 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430009
In Commercial Distribution

  • 00195226000795 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445009
In Commercial Distribution

  • 00195226000788 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360009
In Commercial Distribution

  • 00195226000771 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
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