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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Blood Glucose Test strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
7097C
Not in Commercial Distribution

  • 40301937097506 ()
  • 00301937097508 ()
  • 10301937097505 ()
  • 0193-7097-50 ()
  • 00301937097010 ()
6707202

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. Sold in a carton with a single bottle (50 test strips - RDC # 0193-7080-50), or in a carton of two bottles (100 test strips total - RDC # 0193-7090-21).
ASCENSIA DIABETES CARE US INC.
7080G
In Commercial Distribution

  • 40301939727210 ()
  • 00301937090219 ()
  • 10301937080507 ()
  • 40301939726503 ()
  • 00301937080500 ()
  • 40301937090217 ()
  • 40301937080508 ()
  • 0193-7080-50 ()
  • 00301937080012 ()
  • 40301939603040 ()
  • 40301939602043 ()
6707113

  • Glucose monitoring system IVD, home-use
Blood Glucose Test strips. 25 test strips.
ASCENSIA DIABETES CARE US INC.
7070A
Not in Commercial Distribution

  • 40301939725254 ()
  • 00301937070259 ()
  • 10301937070256 ()
  • 40301937070257 ()
  • 0193-7070-25 ()
  • 00301937070013 ()
6707105

  • 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
OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-046
In Commercial Distribution

  • 20353885011857 ()
  • 00353885011853 ()
  • 53885-046-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-046

  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System.
LifeScan Europe GmbH
024045
In Commercial Distribution

  • 20353885011840 ()
  • 00353885011846 ()
  • 53885-045-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-045

  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System.
LifeScan Europe GmbH
024044
In Commercial Distribution

  • 20353885011833 ()
  • 00353885011839 ()
  • 53885-044-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-044

  • Glucose monitoring system IVD, home-use
OneTouch Verio Blood Glucose Monitoring System.
LifeScan Europe GmbH
024042
In Commercial Distribution

  • 20353885011819 ()
  • 00353885011815 ()
  • 53885-042-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
02404201

  • Glucose monitoring system IVD, home-use
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