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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GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360011
In Commercial Distribution

  • 08426950485698 ()
00027360011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430011
In Commercial Distribution

  • 08426950481058 ()
00027430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
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
DreamStation BiPAP AVAPS 30, Canada
Respironics, Inc.
DreamStation BiPAP AVAPS30 AAM, CA
In Commercial Distribution

  • 00606959040908 ()
CAX1130S12

  • Portable electric ventilator
Dorma 200 with Humidifier, Canada
Respironics, Inc.
Dorma 200 with Humidifier, CA
In Commercial Distribution

  • 00606959038585 ()
CAV201H

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

  • 00606959030053 ()
CA261S

  • Home CPAP unit
DreamStation CPAP with Humidifier, Canada
Respironics, Inc.
DreamStation CPAP with Humidifier, CA
In Commercial Distribution

  • 00606959026537 ()
CAX200H12

  • Home CPAP unit
DreamStation Expert with Humidifier, Canada
Respironics, Inc.
Dreamstation Expert with Humidifier, CA
In Commercial Distribution

  • 00606959053168 ()
CAX501H12

  • 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
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