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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 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 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 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 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 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-419
In Commercial Distribution

  • 20353885001285 ()
  • 00353885001281 ()
  • 53885-419-01 ()

  • Needle Gauge: 30 Gauge
  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
021-419

  • Glucose analyser IVD, home-use
  • Blood lancing device tip
  • Manual blood lancing device, reusable
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 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
OneTouch Ultra2 Blood Glucose Monitoring System with Delica Lancing Device. Uses OneTouch Ultra Blue Test strip
LifeScan Europe GmbH
021-098
In Commercial Distribution

  • 20353885000271 ()
  • 00353885000277 ()
  • 53885-448-01 ()

  • Needle Gauge: 30 Gauge
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
021-098

  • Blood lancing device tip
  • Manual blood lancing device, reusable
  • Glucose monitoring system IVD, home-use
PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips (50 ct)
Prodigy Diabetes Care, LLC
051700
In Commercial Distribution

  • 00384840517004 ()
  • 10384840517001 ()
  • 08484-0517-00 ()
  • 00384843518008 ()
  • 50384840517009 ()
051700

  • Glucose monitoring system IVD, point-of-care
Blood Glucose Monitoring System
OSANG HEALTHCARE Co., Ltd.
IGM-0021B
In Commercial Distribution

  • 8522-0000-51 ()
  • 08809115908971 ()

  • Total Volume: 0.3 Microliter


  • Glucose monitoring system IVD, home-use
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