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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 (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
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
GEM 5000 BG ISE GL COOX 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055445010XC
In Commercial Distribution

  • 08426951027408 ()
00055445010XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM 5000 BG ISE GL COOX 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055430010XC
In Commercial Distribution

  • 08426951027392 ()
00055430010XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM 5000 BG ISE GL COOX 150 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055415010XC
In Commercial Distribution

  • 08426951027385 ()
00055415010XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM 5000 BG ISE GL COOX 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glu, Lac, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055407510XC
In Commercial Distribution

  • 08426951027378 ()
00055407510XC

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Box of 200 Sterile Single-Use Lancing Device 23 Gauge
ASAHI POLYSLIDER COMPANY,LIMITED
024-207
In Commercial Distribution

  • 00812608030255 ()
  • 00812608030231 ()
  • 20812608030235 ()

  • Needle Gauge: 23 Gauge
OTD Safety 23g US/CA 200

  • Manual blood lancing device, single-use
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