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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, 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
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
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 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 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 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 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
GEM 5000 BG ISE COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055407509XC
In Commercial Distribution

  • 08426951027323 ()
00055407509XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscopes Voltage: 100-120 VAC Frequency: 50/60 Hz Electric plug: Type B (USA, CA, JP, MX)
PLASMABIOTICS
Typhoon-V2TD120
In Commercial Distribution

  • 03701354400115 ()

  • Length: 50 Centimeter
  • Width: 50 Centimeter
  • Height: 50 Centimeter


  • Endoscope clean-storage system
GEM 5000 BG ISE GL COOX 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360010XC
In Commercial Distribution

  • 08426951027415 ()
00055360010XC

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