POLYFLUX REVACLEAR

medical_device

Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101, C413129201, C413129301, C413129401, C413129501, C413129601, C414100101, C414100601, C414101001, C414101201, C414101401, C414102101, C414102301, C414103001, C414103401, C414103501, and C414103801.

Gastroenterology-Urology Devices

2

No

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

Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; || Gambro Renal Products, Inc. || Intended for the treatment of acute and chronic renal failure by hemodialysis.

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.

Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.

Polyflux Revaclear Dialyzer, Model Number 110633. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.

Lot No C412207001 to C412209101, C413200101 to C413206001, C414200101 to C414206001

Gastroenterology-Urology Devices

2

No

Worldwide Distribution: US (nationwide) including PR, and countries of: CA, BB, BM, BS, DO and LC.

Polyflux Revaclear Max Dialyzer, Model Number 110634. || The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.