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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 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
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-899
In Commercial Distribution

  • 20353885009762 ()
  • 00353885009768 ()
  • 80353885009764 ()
  • 53885-271-50 ()
022-899

  • Glucose IVD, kit, electrometry
OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-898
In Commercial Distribution

  • 20353885009755 ()
  • 00353885009751 ()
  • 80353885009757 ()
  • 53885-272-10 ()
022-898

  • Glucose IVD, kit, electrometry
OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-100
In Commercial Distribution

  • 20353885008857 ()
  • 00353885008853 ()
  • 53885-452-10 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
021-100

  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-658
In Commercial Distribution

  • 20353885008727 ()
  • 00353885008723 ()
  • 53885-658-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
022-658

  • Glucose monitoring system IVD, home-use
  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose IVD, control
OneTouch Verio Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing For Single Patient use only.
LifeScan Europe GmbH
022-657
In Commercial Distribution

  • 20353885008710 ()
  • 00353885008716 ()
  • 53885-657-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-657

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Verio®Level 4 Control Solution
LifeScan Europe GmbH
022-274
In Commercial Distribution

  • 20353885007775 ()
  • 00353885007771 ()
  • 53885-274-02 ()


  • Glucose monitoring system IVD, point-of-care
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