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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 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST - 08426950807827

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 BG/ISE/GL/COOX/TBILI 300 TEST - 08426950807766

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 BG/ISE/GL/COOX/TBILI 75 TEST - 08426950807643

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 BG/ISE/GL/COOX/TBILI 600 TEST - 08426950807605

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 5000 PAK BG ISE COOX (600 TEST) - 08426951027316

GEM 5000 BG ISE COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360008XC
In Commercial Distribution

  • 08426951027316 ()
00055360008XC

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

GEM Premier 5000 PAK BG ISE COOX (450 TEST) - 08426951027309

GEM 5000 BG ISE COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055445008XC
In Commercial Distribution

  • 08426951027309 ()
00055445008XC

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

GEM Premier 5000 PAK BG ISE COOX (300 TEST) - 08426951027293

GEM 5000 BG ISE COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055430008XC
In Commercial Distribution

  • 08426951027293 ()
00055430008XC

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