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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 (BG/ISE/GL/COOX/Tbili 150 Tests) - 00195226000702

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 (BG/ISE/GL/COOX/Tbili 300 Tests) - 00195226000696

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 (BG/ISE/GL/COOX/Tbili 450 Tests) - 00195226000689

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 (BG/ISE/GL/COOX/Tbili 600 Tests) - 00195226000672

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

HALYARD - 10885632448607

Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 ORTHO WITH FS PP DP AC Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49474
In Commercial Distribution

  • 20885632448604 ()
  • 10885632448607 ()


  • Freestanding patient positioner, single-use

HALYARD - 10885632448584

Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/6 WITH FS PFCPP DS NO AC Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49473
In Commercial Distribution

  • 20885632448581 ()
  • 10885632448584 ()


  • Freestanding patient positioner, single-use

GEM Premier 5000 PAK BG ISE COOX TBILI (600 TEST) - 08426951027361

GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360009XC
In Commercial Distribution

  • 08426951027361 ()
00055360009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (450 TEST) - 08426951027354

GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055445009XC
In Commercial Distribution

  • 08426951027354 ()
00055445009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (300 TEST) - 08426951027347

GEM 5000 BG ISE COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055430009XC
In Commercial Distribution

  • 08426951027347 ()
00055430009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (150 TEST) - 08426951027330

GEM 5000 BG ISE COOX TBILI 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055415009XC
In Commercial Distribution

  • 08426951027330 ()
00055415009XC

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