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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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Element™Plus Meter - 08809115908971

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

Element™ Meter - 08809115908452

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

FreeStyle - 00093815704287

FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • 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

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 Ultra2 - 00353885011853

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 - 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
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