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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REMStar Auto, BlueTooth, Canada
Respironics, Inc.
REMStar Auto, with BlueTooth, CA
In Commercial Distribution

  • 00606959030541 ()
561CABT

  • Home CPAP unit
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
DreamStation BiPAP AVAPS 30, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM, CA
In Commercial Distribution

  • 00606959425507 ()
CAX1130S12

  • Portable electric ventilator
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407508
In Commercial Distribution

  • 00195226000764 ()


  • 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, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415008
In Commercial Distribution

  • 00195226000757 ()


  • 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, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430008
In Commercial Distribution

  • 00195226000740 ()


  • 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, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445008
In Commercial Distribution

  • 00195226000733 ()


  • 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, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360008
In Commercial Distribution

  • 00195226000726 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430010
In Commercial Distribution

  • 08426950807759 ()
00055430010

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