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510(k) Data Aggregation
K Number
K962959Device Name
PERACIDIN DIALYZER REPROCESSING CONCENTRATE
Manufacturer
HDC MEDICAL, INC.
Date Cleared
1998-06-05
(675 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
HDC MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Peracidin™ Dialyzer Reprocessing Concentrate is indicated for the in-virro cleaning and disinfection of hollow fiber dialyzers, classified as follows:
Conventional dialyzer, 21 CFR 876.5820, product code 78 FJI High permeability dialyzer, 21 CFR 876,5860, product code 78 KDI
The product is intended for use only with reprocessing systems, automated or manual, that have been validated by the system manufacturer for use with peracetic acid. The intended use of Peracidin is identical to that of Renalin.
Device Description
Peracidial Dialyzer Reprocessing Concentrate is a stabilized mixture of hydrogen peroxide 27,0% and peroxyacetic acid 4,5%; inert ingredients are 68,5% (nominal concentrations). The concentrate is a clear colorless liquid, is highly acidic, and is completely soluble in water. Peracidim breaks down to acetic acid, water, and oxygen.
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