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510(k) Data Aggregation
K Number
K072158Device Name
AQUA PURE DEIONIZER EXCHANGE SERVICE
Manufacturer
Date Cleared
2008-02-21
(202 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
STAUBACH BARROR WATER SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Aqua Pure DI exchange tanks are used according to current AAMI standards (RD 62) and are intended to supply dialysis grade water, for use in dialysis, concentrate preparation systems, dialyzer reuse systems and rinsing of sterilants. The exchange tanks can be used for either primary water purification or to supply emergency backup water purification for dialysis units. The D.I. exchange tanks for dialysis are only one part of a complete water treatment system and must be used in conjunction within a water treatment system with appropriate pre-treatment and post-treatment.
Device Description
Aqua Pure's D.I. Exchange Tanks for Dialysis are FRP tanks filled with mixed bed resin. Widget connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. Our tanks are designed to supply AAMI standard water for dialysis through ion exchange. The D.I. exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks K991519.
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