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510(k) Data Aggregation
K Number
K200425Device Name
Female Luer Lock Cap
Manufacturer
Date Cleared
2020-10-29
(252 days)
Product Code
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
MedSafety Solutions LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Female Luer Lock Cap is indicated for use as a cap for male Luer fittings on medical devices such as manifolds, stopcocks or IV sets.
Device Description
The Female Luer Lock Cap is an individually packaged, sterile, single use disposable product used to cover male Luer fittings. Luer fittings are commonly used on IV administration products and accessories to provide universal compatibility and are well established in the market. Luer lock fittings are securely joined by means of a tabbed hub on the female fitting which screws into threads in a sleeve on the male fitting. The Female Luer Lock Cap is an injection molded, polyethylene component. Polyethylene material is durable, biologically inert, gamma stable, and used extensively in the medical device industry. The product is terminally gamma sterilized to a Sterility Assurance Level (SAL) of 10-6.
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