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510(k) Data Aggregation
K Number
K183662Device Name
Saline Wound Wash, SteriCleanse(TM)
Manufacturer
Date Cleared
2019-09-12
(259 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Ascent Consumer Products, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
To cleanse minor wounds, scrapes and minor burns
Device Description
Saline Wound Wash is an isotonic sterile saline solution packaged in a bag-in-can (also known as bag-on-valve, BOV) aerosol system. Actuation of the valve device delivers a consistent flow of sterile isotonic saline solution at the wound site. The flow of isotonic saline solution at the wound or abrasion site aids in the removal of foreign material, such as dirt and debris, as well as any necrotic tissue, wound exudate and other extraneous matter. No preservatives are added since the finished device is sterilized by gamma irradiation under parameters that have been validated according to ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 requirements [Sterilization of Health Care Products -Requirements for development, validation and routine control of a sterilization process for medical devices]. Saline Wound Wash passes the USP<71> Sterility Test.
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