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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 4000 PAK BG ISE GL COOX 300 TEST 30 DAY - 08426950440697

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430010
In Commercial Distribution

  • 08426950440697 ()
00027430010

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

GEM 4000 PAK BG ISE GL COOX 600 TEST 21 DAY - 08426950465379

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360010
In Commercial Distribution

  • 08426950465379 ()
00027360010

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

GEM 4000 PAK BG ISE GL COOX 75 TEST 30 DAY - 08426950461081

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407510
In Commercial Distribution

  • 08426950461081 ()
00027407510

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

GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST - 08426950807810

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445010
In Commercial Distribution

  • 08426950807810 ()
00055445010

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

GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST - 08426950807759

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430010
In Commercial Distribution

  • 08426950807759 ()
00055430010

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

GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST - 08426950807698

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415010
In Commercial Distribution

  • 08426950807698 ()
00055415010

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

GEM Premier 5000 PAK BG/ISE/GL/COOX 75 TEST - 08426950807636

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407510
In Commercial Distribution

  • 08426950807636 ()
00055407510

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

GEM Premier 5000 PAK BG/ISE/GL/COOX 600 TEST - 08426950807599

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360010
In Commercial Distribution

  • 08426950807599 ()
00055360010

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

GEM 4000 PAK BG ISE GL COOX BILI 75 TEST 30 DAY - 08426950554714

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407511
In Commercial Distribution

  • 08426950554714 ()
00027407511

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

GEM 4000 PAK BG ISE GL COOX BILI 150 TEST 30 DAY - 08426950485728

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415011
In Commercial Distribution

  • 08426950485728 ()
00027415011

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