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, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 600 Sample 21DAY
INSTRUMENTATION LABORATORY COMPANY
00027360009
In Commercial Distribution

  • 08426950554691 ()
00027360009

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Volumetric Incentive Spirometer with One Way Valve 4000 mL Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56178
In Commercial Distribution

  • 20885632429771 ()
  • 10885632429774 ()


  • Diagnostic spirometer, professional
Volumetric Incentive Spirometer 2500 mL with One Way Valve Polyurethane Clear Adult Use CA/12 Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
56179
In Commercial Distribution

  • 20885632429788 ()
  • 10885632429781 ()


  • Diagnostic spirometer, professional
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445008
In Commercial Distribution

  • 08426950807797 ()
00055445008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430008
In Commercial Distribution

  • 08426950807735 ()
00055430008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415008
In Commercial Distribution

  • 08426950807674 ()
00055415008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407508
In Commercial Distribution

  • 08426950807612 ()
00055407508

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 - 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360008
In Commercial Distribution

  • 08426950807575 ()
00055360008

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Equipment Cover Set Up Cover Clear Polyurethane 70IN x 70IN Polyurethane Clear Non-Sterile CA/50 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56157
In Commercial Distribution

  • 10885632426926 ()
  • 20885632426923 ()


  • Medical equipment/instrument drape, single-use
Equipment Cover Set Up Cover Clear Polyurethane 54IN x 90IN Polyurethane Clear Non-Sterile CA/40 Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
56156
In Commercial Distribution

  • 10885632426919 ()
  • 20885632426916 ()


  • Medical equipment/instrument drape, single-use
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