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510(k) Data Aggregation
K Number
K041884Device Name
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
Manufacturer
Date Cleared
2005-02-28
(231 days)
Regulation Number
876.5665Why did this record match?
Applicant Name (Manufacturer) :
MUELLER WATER CONDITIONING, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Mueller Water Conditioning's Water Purification System for Hemodialysis is intended for use in hemodialysis treatment. The System is used to dilute dialysate concentrate to form dialysate and to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate. When used to produce purified water for dialyzer reprocessing, equipment rinse and disinfection. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.
Device Description
The Mueller RO/Di system for hemodialysis treats incoming facility water to provide water conforming to AAMI standards for hemodialysis use in respect to organic and inorganic substances as well as microbial. The water is intended for use as dilute dialysate, as dilute dialysate, as dilute dialysate, bicarbonate, acetate and sterilant for dialyzer reprocessing.
The core components of the system include carbon filters along with reverse osmosis (RO) unit and portable exchange deionization tanks along with alarms to remove oxidants from the water that are harmful to patient health. The specific configuration of the equipment will depend upon the customer's water quality desires (specifications) beyond the minimum AAMI standards.
Pretreatment is used before the RO unit to match the specific influent water quality to those required by the RO unit manufacturer's specifications. Pretreatment will include multi-media filtration, water softening, carbon filtration, and sediment filtration.
Post treatment is used after the RO unit to polish and monitor the water of any remaining contaminants. Deionization tanks, final filters, UV lamps, storage tanks, repressurization and recirculation pumps, flow meters, and resistivity monitors are examples of post treatment machines.
The Mueller Water Conditioning, Inc. (MWCI) water purification system utilizes no new water treatment technologies. Multimedia filtration, cartridge filtration, carbon filtration, reverse osmosis (R.O.), deionization, ultraviolet light and particulate filtration are the core methods of treatment for this system. The storage, piping, repressurization, recirculation, emergency bypasses, sanitization, labeling, training and customer service round out the efforts to ensure proper delivery of the treated water. All components of the claimed device use identical scientific principles to perform their function.
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