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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 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445010
In Commercial Distribution

  • 00195226000634 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360010
In Commercial Distribution

  • 00195226000627 ()
00077360010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 REX WITH FS PP DP Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49475
In Commercial Distribution

  • 20885632448598 ()
  • 10885632448591 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Polyurethane Foam Blue White CA/6 WITH PFC SCP 4 HTC NO AR Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49457
In Commercial Distribution

  • 20885632448512 ()
  • 10885632448515 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits XL Polyurethane Foam Blue CA/10 W Drawsht No Arm Pro No Headrst Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49445
In Commercial Distribution

  • 20885632444682 ()
  • 10885632444685 ()


  • Freestanding patient positioner, single-use
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407511
In Commercial Distribution

  • 00195226000719 ()
00077407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415011
In Commercial Distribution

  • 00195226000702 ()
00077415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430011
In Commercial Distribution

  • 00195226000696 ()
00077430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445011
In Commercial Distribution

  • 00195226000689 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, tBili, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360011
In Commercial Distribution

  • 00195226000672 ()


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