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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 Class Implantable

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GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 300 Tests) - 00195226000795

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 (BG/ISE/CO-Ox/Tbili 450 Tests) - 00195226000788

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 (BG/ISE/COOX/Tbili 600 Tests) - 00195226000771

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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests) - 00195226000665

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407510
In Commercial Distribution

  • 00195226000665 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests) - 00195226000658

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415010
In Commercial Distribution

  • 00195226000658 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) - 00195226000641

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430010
In Commercial Distribution

  • 00195226000641 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests) - 00195226000634

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445010
In Commercial Distribution

  • 00195226000634 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests) - 00195226000627

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360010
In Commercial Distribution

  • 00195226000627 ()
00077360010

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

GEM Premier 5000 PAK BG ISE COOX TBILI (600 TEST) - 08426951027361

GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360009XC
In Commercial Distribution

  • 08426951027361 ()
00055360009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (450 TEST) - 08426951027354

GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055445009XC
In Commercial Distribution

  • 08426951027354 ()
00055445009XC

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