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®Level 4 Control Solution
LifeScan Europe GmbH
022-274
In Commercial Distribution

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


  • Glucose monitoring system IVD, point-of-care
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 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 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 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
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 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 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
One Touch Ultra Control Solution
LifeScan Europe GmbH
021-416
In Commercial Distribution

  • 20353885006235 ()
  • 00353885006231 ()
  • 53885-937-01 ()
021-416

  • Glucose monitoring system IVD, point-of-care
OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters
LifeScan Europe GmbH
020-963
In Commercial Distribution

  • 20353885004187 ()
  • 00353885004183 ()
  • 80353885004189 ()
  • 30353885004184 ()
  • 53885-963-50 ()
020-963

  • Glucose IVD, kit, electrometry
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