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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 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

GEM Premier 5000 PAK BG ISE COOX TBILI (75 TEST) - 08426951027323

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

GEM Premier 5000 PAK BG ISE GL COOX (600 TEST) - 08426951027415

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 Premier 5000 PAK BG ISE GL COOX (450 TEST) - 08426951027408

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 Premier 5000 PAK BG ISE GL COOX (300 TEST) - 08426951027392

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 Premier 5000 PAK BG ISE GL COOX (150 TEST) - 08426951027385

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 Premier 5000 PAK BG ISE GL COOX (75 TEST) - 08426951027378

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

OneTouch Delica Safety - 00812608030231

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

OneTouch Delica Plus Lancet - 00812608030040

Bag of 10 sterile lancets 30 Gauge
ASAHI POLYSLIDER COMPANY,LIMITED
013-027
In Commercial Distribution

  • 00812608030156 ()
  • 00812608030040 ()
  • 20812608030044 ()

  • Needle Gauge: 30 Gauge
OTDP Lancet Bag 30g US/CA

  • Blood lancing device tip
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