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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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FreeStyle Libre 3 - 00357599818005

FreeStyle Libre 3 Sensor Kit US
ABBOTT DIABETES CARE INC
72081
In Commercial Distribution

  • 30357599818006 ()
  • 00357599818005 ()
  • 57599-0818-00 ()
72081

  • Percutaneous interstitial-fluid glucose monitoring system, electrochemical

OneTouch Ultra2 - 00353885008853

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 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 - 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

OneTouch Ultramini - 00353885000512

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-211
In Commercial Distribution

  • 20353885000516 ()
  • 00353885000512 ()
  • 53885-211-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-211

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

OneTouch Ultramini - 00353885000482

OneTouch Ultramini Blood Glucose Monitoring System with Delica Lancing Device, not for resale or reimbursement. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-208
In Commercial Distribution

  • 20353885000486 ()
  • 00353885000482 ()
  • 53885-208-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-208

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

Equate Blood Glucose Test Strips - 00681131104869

Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
Unistrip Technologies, LLC
038600
In Commercial Distribution

  • 00681131304863 ()
  • 00681131104869 ()
  • 90681131104862 ()
  • 30681131104860 ()
  • 10681131104866 ()
  • 49035-0386-00 ()
038600

  • Glucose IVD, kit, electrometry

OneTouch Ultra Blue - 00353885009713

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
022-895
In Commercial Distribution

  • 20353885009717 ()
  • 00353885009713 ()
  • 80353885009719 ()
  • 53885-245-10 ()
022-895

  • Glucose IVD, kit, electrometry

OneTouch Ultra Blue - 00353885994255

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
020-994
In Commercial Distribution

  • 20353885994259 ()
  • 00353885994255 ()
  • 80353885994251 ()
  • 53885-994-25 ()
020-994

  • Glucose IVD, kit, electrometry

OneTouch Ultra Blue - 00353885009720

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
022-896
In Commercial Distribution

  • 20353885009724 ()
  • 00353885009720 ()
  • 80353885009726 ()
  • 53885-244-50 ()
022-896

  • Glucose IVD, kit, electrometry
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