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 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Test 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360008
In Commercial Distribution

  • 08426950554820 ()
00027360008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415008
In Commercial Distribution

  • 08426950554783 ()
00027415008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407508
In Commercial Distribution

  • 08426950554776 ()
00027407508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430008
In Commercial Distribution

  • 08426950543589 ()
00027430008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 450 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027445008
In Commercial Distribution

  • 08426950446224 ()
00027445008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Equipment Cover Band Bags Clear Polyurethane 40IN x 90IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
55913
In Commercial Distribution

  • 10885632425691 ()
  • 30885632425695 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Band Bags Clear Polyurethane 36IN x 90IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
55909
In Commercial Distribution

  • 10885632425653 ()
  • 30885632425657 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Band Bags Clear Polyurethane 36IN x 70IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
55908
In Commercial Distribution

  • 10885632425646 ()
  • 30885632425640 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Band Bags Clear Polyurethane 5IN x 12IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56159
In Commercial Distribution

  • 10885632426254 ()
  • 20885632426251 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover C-Arm Drape Clear Polyurethane 54IN x 64IN Polyurethane Clear Non-Sterile CA/100 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
55960
In Commercial Distribution

  • 10885632426162 ()
  • 20885632426169 ()


  • Medical equipment/instrument drape, single-use
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