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 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
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 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 Ultra2 Blood Glucose Monitoring System. Uses the OneTouch Ultra Blue Test Strip.
LifeScan Europe GmbH
023-065
In Commercial Distribution

  • 20353885010515 ()
  • 00353885010511 ()
  • 53885-065-01 ()

  • Blood Glucose measurement Level mg/dL
  • Hematocrit 30 - 55%
023-065

  • Glucose analyser IVD, home-use
Precision Xtra Blood Glucose & Ketone Monitoring System
ABBOTT DIABETES CARE INC
99837
In Commercial Distribution

  • 30093815998373 ()
  • 00093815998372 ()
  • 57599-9837-1 ()
99837

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99695
In Commercial Distribution

  • 30093815996959 ()
  • 00093815996958 ()
  • 57599-9695-4 ()
  • 10093815996955 ()
99695

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99694
In Commercial Distribution

  • 30093815996942 ()
  • 00093815996941 ()
  • 57599-9694-5 ()
  • 10093815996948 ()
99694

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xtra Blood Glucose & Ketone Monitoring System
ABBOTT DIABETES CARE INC
98814
In Commercial Distribution

  • 30093815988145 ()
  • 00093815988144 ()
  • 57599-8814-1 ()
98814

  • Multiple clinical chemistry analyte monitoring system IVD, home-use
  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
80050
In Commercial Distribution

  • 30093815800508 ()
  • 00093815800507 ()
  • 57599-0050-1 ()
  • 10093815800504 ()
80050

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
Precision Xtra Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
70745
In Commercial Distribution

  • 30093815707456 ()
  • 00093815707455 ()
  • 57599-0745-1 ()
  • 10093815707452 ()
70745

  • Multiple clinical chemistry analyte monitoring system IVD, point-of-care
  • Multiple clinical chemistry analyte monitoring system IVD, home-use
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