Devices

Contour, Contour TS Blood Glucose Test Strips and Bonus Packs

  • Modèle / numéro de série
    9545C, 9677, 9678, 9679, 9680, 7151G, 7190, 7183, 9615, 7393, 9591, 9591A 9579, 1802, 6181, 7070A, 9725, 9507C, and 9578.   Contour 125 Count Bonus Pack (includes 2-50 Count and 1-25 Count Vials) the following lot numbers:DW0AC3B32A, DW0AC3B32C, DW0BC3B31A, DW0BC3B31B, DW0BC3D05B, DW0CC3B31A, DW0CC3B31B, DW0GC3B31C, DW0GC3B31D, DW0GC3B31F, DW0HC3B32A, DW9MC3B32D, DW9MC3B32E, DW9MC3B33A, and DW9MC3B33B.
  • Classification du dispositif
    Clinical Chemistry and Clinical Toxicology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution and Puerto Rico
  • Description du dispositif
    Contour, Contour TS Blood Glucose Test Strips and Bonus Packs || Intended for self-testing by people with diabetes and healthcare professionals to monitor glucose concentrations in whole blood
  • Manufacturer
    Bayer Healthcare, LLC
  • 1 Event

Fabricant

Bayer Healthcare, LLC
  • Adresse du fabricant
    Bayer Healthcare, LLC, 430 S Beiger Street, Mishawaka IN 46544-3207
  • Société-mère du fabricant (2017)
    Bayer AG
  • Source
    USFDA