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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/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

GEM Premier 7000 with iQM3 PAK (BG/ISE/COOX/Tbili 150 Tests) - 00195226000801

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415009
In Commercial Distribution

  • 00195226000801 ()


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

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

INTERNA® NARROW IMPLANT CA D:4.75 L:11.5 - 08435389822226

No Description
BIOTECHNOLOGY INSTITUTE SL
IIPECA4711
In Commercial Distribution

  • 08435389822226 ()


  • Screw endosteal dental implant, two-piece

INTERNA® NARROW IMPLANT CA D:4.25 L:11.5 - 08435389820796

No Description
BIOTECHNOLOGY INSTITUTE SL
IIPECA4211
In Commercial Distribution

  • 08435389820796 ()


  • Screw endosteal dental implant, two-piece
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