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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 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407510
In Commercial Distribution

  • 00195226000665 ()


  • 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 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415010
In Commercial Distribution

  • 00195226000658 ()


  • 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 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430010
In Commercial Distribution

  • 00195226000641 ()


  • 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 (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
RAPIDPoint® 400 Measurement Cartridge (400 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct. For in vitro diagnostic use with RAPIDPoint ® 400 systems.
Siemens Healthcare Diagnostics Inc.
10329756
In Commercial Distribution

  • 00630414469225 ()
130517

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDPoint® 400 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, Hct for in vitro diagnostic use with RAPIDPoint® 400 systems.
Siemens Healthcare Diagnostics Inc.
10341161
In Commercial Distribution

  • 00630414443492 ()
118679

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
50 blood collection capillary tubes (approx. volume 140µL). For capillary blood collection for the analysis of pH/Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb
Siemens Healthcare Diagnostics Inc.
10314796
In Commercial Distribution

  • 00630414105994 ()
  • 00630414010120 ()
473193

  • Capillary blood collection tube IVD, electrolyte-balanced heparin
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
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