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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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CONTOUR® - 10301937097505

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

CONTOUR® - 10301937070256

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

CONTOUR® - 10301937099509

Blood Glucose Test strips. 50 test strips.
ASCENSIA DIABETES CARE US INC.
7099C
Not in Commercial Distribution

  • 40301937099500 ()
  • 00301937099502 ()
  • 10301937099509 ()
  • 0193-7099-50 ()
  • 00301937099014 ()
6707245

  • Glucose monitoring system IVD, home-use

Abbott - 00357599000691

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 Ultra2 Blood Glucose Monitoring System. - 00353885011860

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 Verio Flex - 00353885011846

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 - 00353885011839

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. - 00353885011815

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

OneTouch Verio Blood Glucose Monitoring System. - 00353885011808

OneTouch Verio Blood Glucose Monitoring System.
LifeScan Europe GmbH
024041
In Commercial Distribution

  • 20353885011802 ()
  • 00353885011808 ()
  • 53885-041-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
02404101

  • Glucose monitoring system IVD, home-use

OneTouch Verio Flex - 00353885012799

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
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