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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 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

GEM Premier 5000 PAK BG ISE COOX (150 TEST) - 08426951027286

GEM 5000 BG ISE COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055415008XC
In Commercial Distribution

  • 08426951027286 ()
00055415008XC

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

GEM Premier 5000 PAK BG ISE COOX (75 TEST) - 08426951027279

GEM 5000 BG ISE COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055407508XC
In Commercial Distribution

  • 08426951027279 ()
00055407508XC

  • 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 150 TEST - 08426950807704

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 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 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 75 Tests) - 00195226000818

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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