Search Results
Found 1 results
510(k) Data Aggregation
K Number
K080703Device Name
BTI FILTRATION DEIONIZATION EXCHANGE TANK; BTI FILTRATION CARBON EXCHANGE TANK
Manufacturer
Date Cleared
2008-06-02
(82 days)
Product Code
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
4M VENTURES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is intended to be used as components of a hemodialysis water purification system to remove organic and inorganic substances from water used to dilute dialysis concentrate to form dialysate, and to produce purified water for other purposes such as dialyzer reprocessing and equipment rinse and disinfection. 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 fresh virgin carbon.
Device Description
BTI Filtration Deionizer and Carbon Tank 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.
The renal care facilities will supply their own water treatment system, which may consist of water softeners, sediment filters, ultra-filtration, reverse osmosis system, alarms, monitors, tanks, and pumps. BTI Filtration will only be providing the activated carbon and deionization components to their systems.
Ask a Question
Ask a specific question about this device
Page 1 of 1