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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 COOX 75 TEST 30 DAY - 08426950554776

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407508
In Commercial Distribution

  • 08426950554776 ()
00027407508

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

GEM 4000 PAK BG ISE COOX 300 TEST 30 DAY - 08426950543589

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430008
In Commercial Distribution

  • 08426950543589 ()
00027430008

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

GEM 4000 PAK BG ISE COOX 450 TEST 30 DAY - 08426950446224

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445008
In Commercial Distribution

  • 08426950446224 ()
00027445008

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

GEM 4000 PAK BG ISE COOX BILI 450 TEST 30 DAY - 08426950554769

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445009
In Commercial Distribution

  • 08426950554769 ()
00027445009

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

GEM 4000 PAK BG ISE COOX BILI 300 TEST 30 DAY - 08426950554745

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430009
In Commercial Distribution

  • 08426950554745 ()
00027430009

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

GEM 4000 BAK BG ISE COOX BILI 150 TEST 30 DAY - 08426950554738

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415009
In Commercial Distribution

  • 08426950554738 ()
00027415009

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

GEM 4000 PAK BG ISE COOX BILI 75 TEST 30 DAY - 08426950554707

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407509
In Commercial Distribution

  • 08426950554707 ()
00027407509

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

GEM 4000 PAK BG ISE COOX BILI 600 TEST 21 DAY - 08426950554691

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360009
In Commercial Distribution

  • 08426950554691 ()
00027360009

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

GEM Premier 5000 PAK BG/ISE/COOX 450 TEST - 08426950807797

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445008
In Commercial Distribution

  • 08426950807797 ()
00055445008

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

GEM Premier 5000 PAK BG/ISE/COOX 300 TEST - 08426950807735

GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430008
In Commercial Distribution

  • 08426950807735 ()
00055430008

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