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 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
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 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 Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
LifeScan Europe GmbH
023-065
In Commercial Distribution

  • 20353885010515 ()
  • 00353885010511 ()
  • 53885-065-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
023-065

  • Glucose analyser IVD, home-use
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters. For Kaiser Permanente Members Only
LifeScan Europe GmbH
023-061
In Commercial Distribution

  • 20353885010485 ()
  • 00353885010481 ()
  • 80353885010487 ()
  • 53885-061-50 ()
023-061

  • Glucose IVD, kit, electrometry
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. For blood glucose testing with the OneTouch Verio Family of Meters.For DME Beneficiaries Only
LifeScan Europe GmbH
022-978
In Commercial Distribution

  • 20353885010034 ()
  • 00353885010030 ()
  • 80353885010036 ()
  • 53885-838-01 ()
022-978

  • Glucose IVD, kit, electrometry
OneTouch Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
022-965
In Commercial Distribution

  • 20353885010010 ()
  • 00353885010016 ()
  • 53885-296-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
022-965

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