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The DialGuard™ device is intended to be used for the reduction of endotoxin from:

1. Dialysate prior to entering the dialyser
2. Water prior to its use for preparation of dialysate
3. Water prior to use for regenerating dialysers.
   DialGuard™ is intended to be used on a regular preventative basis during hemodialysis treatments. Experimental data indicates that DialGuard TM will consistently reduce endotoxin levels to ≤ 0.05 EU/mL. (AAMI standard for water for dialysate is

DialGuard™ is a device used for the reduction of endotoxin from dialysate and water. It consists of a polysulfone housing filled with an affinity resin with polysulfone endcaps. The endcaps are fitted with Quick Connect couplings.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device's performance, organized according to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the DialGuard™ filter are primarily focused on its ability to reduce endotoxin levels. The performance is reported in the context of meeting or exceeding relevant standards.

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