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510(k) Data Aggregation
K Number
K082400Device Name
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
Manufacturer
Date Cleared
2009-02-03
(167 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
CULLIGAN SOFT WATER SERVICE CO.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.
Device Description
The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.
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