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510(k) Data Aggregation
K Number
K191093Device Name
Isopure Dry Acid Dissolution System
Manufacturer
Date Cleared
2020-01-22
(272 days)
Product Code
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
Isopure, Corp.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Isopure Corp Dry Acid Dissolution System is designed to mix dry acid concentrates with purified water to produce an acid concentrate solution for hemodialysis for use in 3- Stream (acid concentrate, bicarbonate concentrate, and water) hemodialysis machines.
Device Description
The Isopure Dry Acid Dissolution System consists mainly of a Mixing Tank, a Distribution and Mixing Pump, a Hopper (with or without an automated opening mechanism), a Venturi inductor, and accompanying hydraulics and control circuits and sensors. The users will enter the dry acid powder mix into the Hopper either manually or by means of the automated bag opening mechanism. The contents of the Hopper will be drawn into the Mixing Tank by means of the Venturi inductor and the Distribution and Mixing Pump. Once all bags have been entered and the solution thoroughly mixed, the reading of the hydrostatic pressure inside the Tank will be converted into a specific gravity value. This in turn will be used to verify that the proper solution has been prepared against a pre-loaded table of values provided by the powder manufacturer. If the solution passes this verification, the system will allow transferring of the solution to the corresponding storage tank in the facility. The tanks will be identified by the use of quick connectors with RFID to prevent the transfer hose from being connected to the wrong tank.
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