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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 Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip.
LifeScan Europe GmbH
023-194
In Commercial Distribution

  • 20353885010713 ()
  • 00353885010719 ()
  • 53885-194-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
  • Needle Gauge: 30 Gauge
023-194

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Manual blood lancing device, reusable
  • Blood lancing device tip
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-932
In Commercial Distribution

  • 20353885011765 ()
  • 00353885011761 ()
  • 53885-932-02 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 20 - 60%
023-932

  • Glucose analyser IVD, home-use
  • Glucose IVD, kit, electrometry
  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System. Uses the OneTouch Verio Test Strip. Not for Resale or Reimbursement
LifeScan Europe GmbH
023-270
In Commercial Distribution

  • 20353885010973 ()
  • 00353885010979 ()
  • 53885-271-01 ()

  • Hematocrit 20 - 60%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
023-270

  • Glucose analyser IVD, home-use
  • Glucose monitoring system IVD, home-use
  • Glucose IVD, kit, electrometry
  • Manual blood lancing device, reusable
  • Blood lancing device tip
Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2883
In Commercial Distribution

  • 40301932883500 ()
  • 00301932883502 ()
  • 10301932883509 ()
  • 0193-2882-50 ()
  • 00301932883014 ()
7081683

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
Reagent Strips for Urinalysis: Ketone; Glucose
ASCENSIA DIABETES CARE US INC.
2882
In Commercial Distribution

  • 40301932882213 ()
  • 00301932882215 ()
  • 10301932882212 ()
  • 0193-2882-21 ()
  • 00301932882017 ()
15197

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
FreeStyle Unistik 2
ABBOTT DIABETES CARE INC
70428
In Commercial Distribution

  • 30093815704288 ()
  • 00093815704287 ()
  • 99073-0704-28 ()
  • 10093815704284 ()
70428

  • Glucose monitoring system IVD, home-use
Abbott SF Single Use Lancing Device
ABBOTT DIABETES CARE INC
70901
Not in Commercial Distribution

  • 30357599000692 ()
  • 00357599000691 ()
  • 99073-0709-01 ()
  • 10357599000698 ()
70901

  • Glucose monitoring system IVD, home-use
OneTouch Verio Flex Blood Glucose Monitoring System
LifeScan Europe GmbH
024-336
In Commercial Distribution

  • 20353885012793 ()
  • 00353885012799 ()
  • 53885-336-01 ()
024-336

  • Glucose monitoring system IVD, home-use
OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-047
In Commercial Distribution

  • 20353885011864 ()
  • 00353885011860 ()
  • 53885-047-01 ()

  • Do not refrigerate
  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-047

  • Glucose monitoring system IVD, home-use
OneTouch Ultra2 Blood Glucose Monitoring System.
LifeScan Europe GmbH
024-046
In Commercial Distribution

  • 20353885011857 ()
  • 00353885011853 ()
  • 53885-046-01 ()

  • Hematocrit 30 - 55%
  • Blood Glucose measurement Level mg/dL
  • Needle Gauge: 30 Gauge
024-046

  • Glucose monitoring system IVD, home-use
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