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510(k) Data Aggregation
K Number
K102892Device Name
ASI DEIONIZER & CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Manufacturer
Date Cleared
2011-02-03
(126 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
AQUA SCIENCES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ASI Deionizer and Carbon Exchange Tank Service for hemodialysis are intended to be used in a hemodialysis facility according to ANSI/AAMI-RD62:2006 standards to supply purified water for use in hemodialysis. These exchange tanks are components of a larger water treatment system employing adequate pretreatment and post treatment sections. These exchange tanks are not to be used alone. Upon exhaustion, these tanks will be replaced with other Deionization Tanks containing newly regenerated resin or with new resin altogether, or in the case of Carbon Tanks, with tanks containing virgin carbon. Federal law restricts this device to sale by or on the order of a physician for use in hemodialysis applications.
Device Description
Aqua Sciences, Inc. Mixed Bed Deionization Exchange Tanks (DI) are Fiberglass Reinforced Polypropylene (FRP) tanks filled with mixed bed deionizing resin. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The DI Exchange Tanks are dedicated for ion exchange resin only. Our tanks are designed to deliver Association for the Advancement of Medical Instrumentation (AAMI) standard water through an ion exchange process.
Aqua Sciences, Inc. Carbon Exchange Tanks are Fiberglass Reinforced Polypropylene (FRP) tanks filled with new activated carbon. The tank sizes are common for the Dialysis industry with similar inlet and outlet fittings, PVC heads and tank distributors. The Carbon Exchange Tanks are dedicated for carbon only and used to remove chlorine and chloramines.
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