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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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OneTouch Verio - 00353885012034

OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.
LifeScan Europe GmbH
024-174
In Commercial Distribution

  • 20353885012038 ()
  • 00353885012034 ()
  • 80353885012030 ()
  • 53885-174-50 ()
024-174

  • Glucose IVD, kit, electrometry

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

OneTouch Verio Flex - 00353885011761

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-932
In Commercial Distribution

  • 20353885011765 ()
  • 00353885011761 ()
  • 53885-932-02 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
023-932

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Glucose monitoring system IVD, home-use

OneTouch Verio Flex - 00353885010979

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
  • Blood lancing device tip

OneTouch Verio Flex - 00353885010719

OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
LifeScan Europe GmbH
023-194
In Commercial Distribution

  • 20353885010713 ()
  • 00353885010719 ()
  • 53885-194-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
  • Needle Gauge: 30 Gauge
023-194

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
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