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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Duosolâ„¢ Bicarb 32 Dialysate K2/Ca0 2x5000 mL (4554)
B. BRAUN MEDICAL INC.
4554
In Commercial Distribution

  • 04046963112202 ()
  • 04046963112196 ()

  • HCO3- concentration (mEq/L) : 32.000 MEQ
  • Ca++ concentration (mEq/L) : 0.000 MEQ
  • Volume : 5000.000 ML
  • K+ concentration (mEq/L) : 2.000 MEQ
4554

  • Haemodialysis concentrate
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445010
In Commercial Distribution

  • 08426950807810 ()
00055445010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430010
In Commercial Distribution

  • 08426950807759 ()
00055430010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415010
In Commercial Distribution

  • 08426950807698 ()
00055415010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407510
In Commercial Distribution

  • 08426950807636 ()
00055407510

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360010
In Commercial Distribution

  • 08426950807599 ()
00055360010

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407511
In Commercial Distribution

  • 08426950554714 ()
00027407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415011
In Commercial Distribution

  • 08426950485728 ()
00027415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445011
In Commercial Distribution

  • 08426950485711 ()
00027445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360011
In Commercial Distribution

  • 08426950485698 ()
00027360011

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