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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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GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445011
In Commercial Distribution

  • 08426950807827 ()
00055445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430011
In Commercial Distribution

  • 08426950807766 ()
00055430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415011
In Commercial Distribution

  • 08426950807704 ()
00055415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407511
In Commercial Distribution

  • 08426950807643 ()
00055407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360011
In Commercial Distribution

  • 08426950807605 ()
00055360011

  • 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 (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 (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 (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 (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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