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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 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027407509
In Commercial Distribution

  • 08426950554707 ()
00027407509

  • 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 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
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
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
Foam Positioner Straps Blue White 22X2 IN Polyurethane Foam Blue White CA/50 POSITIONING STRAPS Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49492
In Commercial Distribution

  • 20885632448697 ()
  • 10885632448690 ()


  • Freestanding patient positioner, single-use
INSTANT COLD PACK LARGE 6X9 IN UREA BLEND CA 24 NO SLEEVE SINGLE PT USE Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51787
In Commercial Distribution

  • 20885632413862 ()
  • 10885632413865 ()


  • Hot/cold therapy pack, single-use
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