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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/GL/COOX 600 TEST - 08426950807599

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 4000 PAK BG ISE GL COOX BILI 75 TEST 30 DAY - 08426950554714

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 4000 PAK BG ISE GL COOX BILI 150 TEST 30 DAY - 08426950485728

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 4000 PAK BG ISE GL COOX BILI 450 TEST 30 DAY - 08426950485711

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 4000 PAK BG ISE GL COOX BILI 600 TEST 21 DAY - 08426950485698

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

GEM 4000 PAK BG ISE GL COOX BILI 300 TEST 30 DAY - 08426950481058

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glu, Lac, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 300 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027430011
In Commercial Distribution

  • 08426950481058 ()
00027430011

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

CA19-9 MMab - B502BSB51110

CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 1 ml
In Commercial Distribution

  • B502BSB51110 ()
BSB 5111

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody

CA19-9 MMab - B502BSB51100

CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.5 ml
In Commercial Distribution

  • B502BSB51100 ()
BSB 5110

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody

CA19-9 MMab - B502BSB51090

CA 19-9 is a mouse monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Concentrate, 0.1 ml
In Commercial Distribution

  • B502BSB51090 ()
BSB 5109

  • Cancer antigen 19-9 (CA19-9) GI IVD, antibody

HALYARD - 10885632448683

Foam Positioner Prone and Lateral Head White Polyurethane Foam White CA/15 PRONE AND LATERAL HEAD POSITIONING Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49483
In Commercial Distribution

  • 20885632448680 ()
  • 10885632448683 ()


  • Freestanding patient positioner, single-use
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