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 Class Implantable

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GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 450 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044345008
In Commercial Distribution

  • 08426951070848 ()
00044345008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 300 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044330008
In Commercial Distribution

  • 08426951070831 ()
00044330008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 150 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044315008
In Commercial Distribution

  • 08426951070824 ()
00044315008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK for Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct 75 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044307508
In Commercial Distribution

  • 08426951070817 ()
00044307508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 450 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044345010
In Commercial Distribution

  • 08426951070800 ()
00044345010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 300 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044330010
In Commercial Distribution

  • 08426951070794 ()
00044330010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 150 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044315010
In Commercial Distribution

  • 08426951070787 ()
00044315010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 75 test PAK
INSTRUMENTATION LABORATORY COMPANY
00044307510
In Commercial Distribution

  • 08426951070770 ()
00044307510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407508
In Commercial Distribution

  • 08426950554776 ()
00027407508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445008
In Commercial Distribution

  • 08426950446224 ()
00027445008

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