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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FreeStyle Precision H Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
80116
In Commercial Distribution

  • 30093815801161 ()
  • 00093815801160 ()
  • 57599-0116-5 ()
  • 10093815801167 ()
80116

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
FreeStyle Precision Pro Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
71288
In Commercial Distribution

  • 30093815712887 ()
  • 00093815712886 ()
  • 57599-1288-4 ()
  • 10093815712883 ()
71288

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
FreeStyle Precision Pro Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
71284
In Commercial Distribution

  • 30093815712849 ()
  • 00093815712848 ()
  • 57599-1284-5 ()
  • 10093815712845 ()
71284

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xceed Pro Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
70935
In Commercial Distribution

  • 35021791709350 ()
  • 00093815709350 ()
  • 57599-0935-4 ()
  • 10093815709357 ()
70935

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xceed Pro Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
70932
In Commercial Distribution

  • 30093815709320 ()
  • 00093815709329 ()
  • 57599-0932-5 ()
  • 10093815709326 ()
70932

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 08809115908452 ()
  • 8522-0000-22 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
Abbott SF Single Use Lancing Device
ABBOTT DIABETES CARE INC
70901
Not in Commercial Distribution

  • 30357599000692 ()
  • 00357599000691 ()
  • 99073-0709-01 ()
  • 10357599000698 ()
70901

  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System
LifeScan Europe GmbH
024-336
In Commercial Distribution

  • 20353885012793 ()
  • 00353885012799 ()
  • 53885-336-01 ()
024-336

  • Glucose monitoring system IVD, home-use
OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-047
In Commercial Distribution

  • 20353885011864 ()
  • 00353885011860 ()
  • 53885-047-01 ()

  • Do not refrigerate
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-047

  • Glucose monitoring system IVD, home-use
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