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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 - 00353885007764

OneTouch Verio®Level 3 Control Solution
LifeScan Europe GmbH
022-273
In Commercial Distribution

  • 53885-273-02 ()
  • 00353885007764 ()
  • 20353885007768 ()
022-273

  • Glucose monitoring system IVD, point-of-care

OneTouch Verio - 00353885007733

OneTouch Verio Blood Glucose Test Strips. In vitro Diagnostic. For Self-testing. Use with OneTouch Verio Family of Meters
LifeScan Europe GmbH
022-270
In Commercial Distribution

  • 20353885007737 ()
  • 00353885007733 ()
  • 80353885007739 ()
  • 53885-270-25 ()
022-270

  • Glucose IVD, kit, electrometry

OneTouch Verio IQ - 00353885007719

OneTouch Verio IQ Blood Glucose Monitoring System. For in vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-268
In Commercial Distribution

  • 20353885007713 ()
  • 00353885007719 ()
  • 53885-854-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
022-268

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

OneTouch Verio IQ - 00353885007702

OneTouch Verio IQ Blood Glucose Monitoring System. For In vitro diagnostic use. For self-testing
LifeScan Europe GmbH
022-267
In Commercial Distribution

  • 20353885007706 ()
  • 00353885007702 ()
  • 53885-267-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
022-267

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

OneTouch SureSoft - 00353885006842

One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-141
In Commercial Distribution

  • 20353885006846 ()
  • 00353885006842 ()
  • 53885-141-10 ()
  • 80353885006824 ()

  • Needle Gauge: 18 Gauge


  • Manual blood lancing device, single-use

One Touch SureSoft - 00353885006835

One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-140
In Commercial Distribution

  • 20353885006839 ()
  • 00353885006835 ()
  • 53885-140-20 ()
  • 80353885006831 ()

  • Needle Gauge: 28 Gauge


  • Manual blood lancing device, single-use

One Touch SureSoft - 00353885006828

One Touch SureSoft Single Use Disposable Lancing Device
LifeScan Europe GmbH
021-139
In Commercial Distribution

  • 53885-139-20 ()
  • 00353885006828 ()
  • 80353885006824 ()
  • 20353885006822 ()

  • Needle Gauge: 21 Gauge


  • Manual blood lancing device, single-use

OneTouch Ultramini - 00353885002684

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-913
In Commercial Distribution

  • 20353885002688 ()
  • 00353885002684 ()
  • 53885-913-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-913

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

OneTouch Ultramini - 00353885002677

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-911
In Commercial Distribution

  • 20353885002671 ()
  • 00353885002677 ()
  • 53885-911-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-911

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

OneTouch Ultramini - 00353885001311

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-422
In Commercial Distribution

  • 20353885001315 ()
  • 00353885001311 ()
  • 53885-422-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-422

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