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510(k) Data Aggregation
K Number
K201876Device Name
Soteria Bed Barrier
Manufacturer
Date Cleared
2022-09-01
(786 days)
Product Code
Regulation Number
880.6190Why did this record match?
Applicant Name (Manufacturer) :
Trinity Guardion
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Soteria Bed Barrier is a cover for compatible bed decks and mattresses to provide a protective physical barrier between the equipment and the patient. The device is intended to prevent soiling of bed decks and mattresses, helping to reduce contamination during use.
The Soteria Bed Barriers are classified as level 3 per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.
Device Description
The Soteria Bed Barrier is a mattress cover that fits securely over a healthcare mattress and bed deck and attaches to the bed frame. The device is available in multiple configurations to fit specific mattresses and beds, attaching with hooks or clips on each side and the head and foot section of the mattress fit inside a pocket allowing fitted sheets to work over the mattress. Color coding of the label used by the laundry and edge ribbon correspond to compatible beds and mattresses, each barrier model has a different ribbon color. The Soteria Bed Barrier helps to reduce contamination of the underlying surfaces by preventing the penetration of fluids. The Soteria Bed Barrier is a nonsterile reusable device that is laundered in accordance with the validated procedure to remove microbes and spores between each patient use. The Soteria Bed Barrier is removed from the mattress/bed deck for laundering upon soiling or between patient uses. After laundering and inspection, the product is then folded and wrapped with appropriate labels to be used again.
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