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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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Halyard - 10885632444685

Foam Positioner OR Table Positioning Kits XL Polyurethane Foam Blue CA/10 W Drawsht No Arm Pro No Headrst Not made with Natural Rubber Latex HALYARD
OWENS & MINOR DISTRIBUTION, INC.
49445
In Commercial Distribution

  • 20885632444682 ()
  • 10885632444685 ()


  • Freestanding patient positioner, single-use

iBEAM - 04056719001100

iBEAM® evo Couchtop CA is compatible to Siemens ZXT, Varian ETR and Nucletron Simulix table pedestals with the configuration of the respective Ibeam Couchbase Adapters.
3C-Medical Intelligence GmbH
P10105-163
In Commercial Distribution

  • 04056719001100 ()
P10105-163

  • Accelerator system table, non-powered

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 75 Tests) - 00195226000665

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (75 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077407510
In Commercial Distribution

  • 00195226000665 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 150 Tests) - 00195226000658

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (150 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077415010
In Commercial Distribution

  • 00195226000658 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 300 Tests) - 00195226000641

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (300 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077430010
In Commercial Distribution

  • 00195226000641 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 450 Tests) - 00195226000634

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (450 Tests, 31 days)
INSTRUMENTATION LABORATORY COMPANY
00077445010
In Commercial Distribution

  • 00195226000634 ()


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

GEM Premier 7000 with iQM3 PAK (BG/ISE/GL/COOX 600 Tests) - 00195226000627

GEM Premier 7000 with iQM3 PAK pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 (600 Tests, 21 days)
INSTRUMENTATION LABORATORY COMPANY
00077360010
In Commercial Distribution

  • 00195226000627 ()
00077360010

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

GEM Premier 5000 PAK BG ISE COOX TBILI (600 TEST) - 08426951027361

GEM 5000 BG ISE COOX TBILI 600 Test PAK 21 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055360009XC
In Commercial Distribution

  • 08426951027361 ()
00055360009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (450 TEST) - 08426951027354

GEM 5000 BG ISE COOX TBILI 450 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055445009XC
In Commercial Distribution

  • 08426951027354 ()
00055445009XC

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

GEM Premier 5000 PAK BG ISE COOX TBILI (300 TEST) - 08426951027347

GEM 5000 BG ISE COOX TBILI 300 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge)
INSTRUMENTATION LABORATORY COMPANY
00055430009XC
In Commercial Distribution

  • 08426951027347 ()
00055430009XC

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