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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 - 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 Verio - 00353885008723

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

PRODIGY Astro PRO Blood Glucose Monitoring System - 00384840517752

PRODIGY Astro PRO Blood Glucose Monitoring System For Professional Use on Multiple Patients
Prodigy Diabetes Care, LLC
051775
In Commercial Distribution

  • 00384840517752 ()
  • 30384840517753 ()
  • 08484-0517-75 ()
051775

  • Glucose monitoring system IVD, point-of-care

PRODIGY ASTRO PRO No Coding Blood Glucose Test Strips - 00384840517004

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

OneTouch Ultra - 00353885458023

One Touch Ultra Control Solution
LifeScan Europe GmbH
010-458
In Commercial Distribution

  • 20353885458027 ()
  • 00353885458023 ()
  • 53885-458-02 ()
  • 80353885458029 ()
010-458

  • Glucose monitoring system IVD, point-of-care

OneTouch Ultrasoft - 00353885393102

OneTouch Ultrasoft Lancets
LifeScan Europe GmbH
020-393
In Commercial Distribution

  • 20353885393106 ()
  • 00353885393102 ()
  • 53885-393-10 ()
  • 80353885393108 ()

  • Needle Gauge: 28 Gauge
020-393

  • Glucose monitoring system IVD, point-of-care

OneTouch Verio - 00353885007771

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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