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510(k) Data Aggregation
K Number
K083712Device Name
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
Manufacturer
Date Cleared
2009-07-10
(207 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
DIPURE, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.
The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.
Device Description
DiPure's DI Exchange Tanks for Dialysis are approved tanks filled with mixed bed resin. 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 DI exchange tanks are based on the Ameriwater Dialysis Deionizer Exchange Tanks.
DiPure's Carbon Exchange Tanks for Dialysis are approved tanks filled with activated carbon. Connectors are used in conjunction with a machined PVC schedule 80 head, stand pipe, fill port, and distributor basket. These tanks are designed to remove chlorine and chloramines. These tanks are based on the Ameriwater Carbon Exchange Tanks.
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