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 pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 450 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055445011
In Commercial Distribution

  • 08426950807827 ()
00055445011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 300 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055430011
In Commercial Distribution

  • 08426950807766 ()
00055430011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 150 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055415011
In Commercial Distribution

  • 08426950807704 ()
00055415011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days
INSTRUMENTATION LABORATORY COMPANY
00055407511
In Commercial Distribution

  • 08426950807643 ()
00055407511

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Glucose, Lactate, Hct, tBili, tHb, O2Hb, COHb, MetHb, HHb, sO2 600 Test 21 Days
INSTRUMENTATION LABORATORY COMPANY
00055360011
In Commercial Distribution

  • 08426950807605 ()
00055360011

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
Replacement Pad for Hill-Rom 941 CA Stretcher: 5"T Pressure Relief Memory Foam with Fusion Conductive Covering. 27"W x 78"L x 5"T
Coulmed Products Group LLC
THR06-PR
In Commercial Distribution

  • 10810087352292 ()
THR06-PR

  • Stretcher mattress
Foam Positioner OR Table Positioning Kits Blue White Polyurethane Foam Blue White CA/12 WITH AC AXILLA CUFF Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49477
In Commercial Distribution

  • 20885632448611 ()
  • 10885632448614 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Polyurethane Foam Blue White CA/6 WITH PFC SCP 4 HTC AR Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49456
In Commercial Distribution

  • 20885632448505 ()
  • 10885632448508 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Standard Polyurethane Foam Blue CA/6 W XL Arm Prot Headrst Drawsht Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49449
In Commercial Distribution

  • 20885632444729 ()
  • 10885632444722 ()


  • Freestanding patient positioner, single-use
Foam Positioner OR Table Positioning Kits Standard Polyurethane Foam Blue CA/10 W Drawsht Headrst No Arm Prot Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49447
In Commercial Distribution

  • 20885632444705 ()
  • 10885632444708 ()


  • Freestanding patient positioner, single-use
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