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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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Precision Xtra - 00093815998785

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99878
In Commercial Distribution

  • 30093815998786 ()
  • 00093815998785 ()
  • 57599-9878-5 ()
  • 10093815998782 ()
99878

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

Precision Xtra - 00093815998778

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99877
In Commercial Distribution

  • 30093815998779 ()
  • 00093815998778 ()
  • 57599-9877-5 ()
  • 10093815998775 ()
  • 40093815998776 ()
99877

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

Precision Xtra - 00093815998389

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99838
In Commercial Distribution

  • 30093815998380 ()
  • 00093815998389 ()
  • 57599-9838-4 ()
  • 10093815998386 ()
99838

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

Precision Xtra - 00093815997283

Precision Xtra Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
99728
In Commercial Distribution

  • 40093815997281 ()
  • 00093815997283 ()
  • 30093815997284 ()
  • 57599-9728-4 ()
  • 10093815997280 ()
99728

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

Precision Xtra - 00093815715023

Precision Xtra Blood Glucose & Ketone Monitoring System
ABBOTT DIABETES CARE INC
71502
Not in Commercial Distribution

  • 30093815715024 ()
  • 00093815715023 ()
  • 57599-1502-1 ()
71502

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

OneTouch Verio Flex - 00353885011761

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

Abbott - 00357599833008

Abbott SF Single Use Lancing Device 200ct, US
ABBOTT DIABETES CARE INC
78632
In Commercial Distribution

  • 10357599000698 ()
  • 57599-0833-00 ()
  • 00357599833008 ()
  • 30357599833009 ()
78632

  • Manual blood lancing device, single-use

FreeStyle Precision H - 00093815801160

FreeStyle Precision H Blood Glucose Test Strips
ABBOTT DIABETES CARE INC
80116
In Commercial Distribution

  • 30093815801161 ()
  • 00093815801160 ()
  • 57599-0116-5 ()
  • 10093815801167 ()
80116

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

FreeStyle Precision Pro - 00093815712886

FreeStyle Precision Pro Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
71288
In Commercial Distribution

  • 30093815712887 ()
  • 00093815712886 ()
  • 57599-1288-4 ()
  • 10093815712883 ()
71288

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

Precision Xceed Pro - 00093815709350

Precision Xceed Pro Blood ß-Ketone Test Strips
ABBOTT DIABETES CARE INC
70935
In Commercial Distribution

  • 35021791709350 ()
  • 00093815709350 ()
  • 57599-0935-4 ()
  • 10093815709357 ()
70935

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