Polyflux Revaclear Max, Capillary Dialyzer

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.

Gastroenterology-Urology Devices

2

No

Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.

Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; || Gambro Renal Products, Inc. || Intended for the treatment of acute and chronic renal failure by hemodialysis.