REVACLEAR Dialyzer Technology - Baxter

1 REVACLEAR Dialyzer TechnologyMaking possible Membrane1 Designed to remove critical uremic toxins such as urea while retaining important proteins like albumin and other similarly-sized molecules. In addition to the small molecular weight molecules, the REVACLEAR Dialyzer s membrane removes a large fraction of middle molecules similarly sized to Beta-2 Microglobulin (SC = , 70%).Sterilization and Priming1 REVACLEAR Dialyzer uses steam sterilization; it is never sterilized by E-beam or EtO. At a minimum, 300 mL of saline would be required for Success With more than 50 million sold in the and Canada, the REVACLEAR Dialyzer has been one of Baxter s most successful dialyzers to your expectation with experience REVACLEAR Dialyzer TechnologyREVACLEARREVACLEAR MAXREVACLEAR 300 REVACLEAR 400 hemodialysis QD =500 mL/min, UF=0 mL/minQB (mL/min)

2 2003004005002003004005002003004005006002 00300400500600 Urea196271321353196272323356198282339376 400198281338375401 Creatinine189250289316191256298326195265 311341362195267315348370 Phosphate1852392742981852422783031912562 97324343191255297326346 Vitamin B121441701861971461741912041581912112252 35158191213228240 hemodialysis QD =800 mL/min, UF=0 mL/minQB (mL/min)20030040050020030040050020030040 0500600200300400500600 Urea199286355408199286355408200293371432 479199292369430477 Creatinine194269324364195273330373197281 345393430198283348398437 Phosphate1912593073431912603093451962733 30373406195272330373406 Vitamin B121541872082231551892122281692112402602 76167208236256272 SpecificationsBlood flow rate (mL/min)200-500200-500200-600200-600 Dialysate flow (mL/min)800300-800800300-800 MembraneMaterialPAES/PVPPAES/PVPPAES/PVP PAES/PVPS urface area (m2) Coefficient in vitro ( ) (Bovine blood, hematocrit=32%, protein=60 g/l, 37 C)50486054 Priming volume (mL)

3 847410093 Residual blood volume (mL)<1<1<1<1 Fiber DimensionsWall Thickness Membrane ( m)35 Inner Diameter Hollow Fiber ( m)190 Maximum TMP (mmHg)600 Sterilization agentSteamSieving Coefficient in vitro. Typical values measured with REVACLEAR Dialyzer according to EN1283 Vitamin < 300 REVACLEAR MAXREVACLEAR 400 Product Code:110633114745110634114746 REVACLEAR Dialyzer Family Clinical DataClearance in vitro (mL/min) +/-10% REVACLEAR and REVACLEAR MAX Dialyzer is indicated for treatment of chronic and acute renal failure by 300 and REVACLEAR 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis or hemdiafiltrationFor the safe and proper use of the REVACLEAR dialyzers, refer to the warnings, precautions and detailed directions for use in the Instructions for Use.

4 For single use only. References1. REVACLEAR , REVACLEAR MAX and REVACLEAR 300 and 400 Instructions for Data on file, Gambro Business control reporting as of December 31, 2013. Baxter Corporation7125 Mississauga RoadMississauga, ON L5N 0C2 CAMP/G82/16-0001 Contact your local Baxter sales representative to learn more about the product.