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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 4000 BAK BG ISE COOX BILI 150 TEST 30 DAY - 08426950554738

GEM Premier 4000 pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Hct, tBili, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 150 Test 30DAY
INSTRUMENTATION LABORATORY COMPANY
00027415009
In Commercial Distribution

  • 08426950554738 ()
00027415009

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

GEM 4000 PAK BG ISE COOX BILI 75 TEST 30 DAY - 08426950554707

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 4000 PAK BG ISE COOX BILI 600 TEST 21 DAY - 08426950554691

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

Halyard - 10885632429774

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

Halyard - 10885632413865

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

Halyard - 10885632406881

Bordered Gauze Adhesive Island Dressing 4x4 Square gauze white CA/200 Sterile Bordered Gauze White NOT MADE WITH NaTURAL RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
50195
In Commercial Distribution

  • 20885632406888 ()
  • 10885632406881 ()
  • 30885632406885 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

Halyard - 10885632406874

Bordered Gauze Adhesive Island Dressing 2x2 Square gauze white CA/400 Sterile Bordered Gauze White NOT MADE WITH Natural RUBBER LATEX Halyard
OWENS & MINOR DISTRIBUTION, INC.
50194
In Commercial Distribution

  • 30885632406878 ()
  • 20885632406871 ()
  • 10885632406874 ()


  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

HALYARD - 10885632448690

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

Halyard - 10885632429781

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

Halyard - 10885632413759

PERINEAL PACK COLD 4X11IN UREA BLEND CA 24 PAD W/AD STRIP REG SINGLE PT Not made with Natural Rubber Latex Halyard
OWENS & MINOR DISTRIBUTION, INC.
51773
In Commercial Distribution

  • 20885632413756 ()
  • 10885632413759 ()


  • Hot/cold therapy pack, single-use
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