Polyflux Revaclear Max, Capillary Dialyzer

  • Model / Serial
    Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
  • Product Description
    Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; || Gambro Renal Products, Inc. || Intended for the treatment of acute and chronic renal failure by hemodialysis.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
  • Manufacturer Parent Company (2017)
  • Source
    USFDA