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510(k) Data Aggregation
K Number
K033118Device Name
BIPRO MODEL SDS-CB200
Manufacturer
MEDICAL SOLUTIONS INTERNATIONAL
Date Cleared
2004-06-28
(272 days)
Product Code
FIN
Regulation Number
876.5820Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL SOLUTIONS INTERNATIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis.
Device Description
The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb concentrates and RO water for distribution as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine.
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