Gambro Renal Products Inc

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.

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.