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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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S7375 Cleaning Solution 175mL for ABL7XX
Radiometer Medical ApS
944-123
Not in Commercial Distribution

  • 05700699441232 ()
944-123

  • Wash/cleaning solution IVD, automated/semi-automated system
S7865 AutoCheck 6+, level 4 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-097
In Commercial Distribution

  • 55700699440971 ()
  • 05700699440976 ()
944-097

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7855 AutoCheck 6+, level 3 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-096
In Commercial Distribution

  • 55700699440964 ()
  • 05700699440969 ()
944-096

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7845 AutoCheck 6+, level 2 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-095
In Commercial Distribution

  • 55700699440957 ()
  • 05700699440952 ()
944-095

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
S7835 AutoCheck 6+, level 1 box of 30 ampoules, for ABL8XX
Radiometer Medical ApS
944-094
In Commercial Distribution

  • 55700699440940 ()
  • 05700699440945 ()
944-094

  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
D8088+D8089 Crea membrane box A+B, with 2xA and 2xB membrane units, for ABL8XX
Radiometer Medical ApS
942-073
In Commercial Distribution

  • 05700699420732 ()
942-073

  • Creatinine IVD, reagent
D7077 Lac membrane box (4 units) for ABL7XX/8XX
Radiometer Medical ApS
942-066
In Commercial Distribution

  • 05700699420664 ()
  • 55700699420669 ()
942-066

  • Lactate electrode IVD
No Description
FUJIFILM IRVINE SCIENTIFIC, INC.
91005-500ML
In Commercial Distribution

  • 00857515006160 ()

  • Total Volume: 500 Milliliter
91005

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang Medium BMC with Gentamicin
FUJIFILM IRVINE SCIENTIFIC, INC.
91004-500ML
In Commercial Distribution

  • 00857515006153 ()

  • Total Volume: 500 Milliliter
91004

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
Chang C 70ML Frozen Supplement
FUJIFILM IRVINE SCIENTIFIC, INC.
C108-70ML
In Commercial Distribution

  • 00857515006122 ()

  • Total Volume: 70 Milliliter
C108

  • Amniotic fluid/chorionic villus sample (CVS) karyotype suspension IVD, reagent
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