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510(k) Data Aggregation

    K Number
    K200082
    Device Name
    BD Univia RightFit Enteral Extension Sets and Transitional Adapters
    Manufacturer
    Date Cleared
    2020-07-30

    (197 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPS Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BD UniVia™ RightFit enteral extension set is indicated for use in neonatal, pediatric and adult patients in connection with nasogastric enteral feeding tube to provide nutrition via nasal or oral gastric tube placements. BD UniVia™ RightFit transition adapter allows connection of BD UniVia™ RightFit Extension Sets to non-BD UniVia™ RightFit enteral systems.
    Device Description
    Enteral Extension Sets are intended to provide access from a feeding tube to a syringe or nutritional source accepting a connector for enteral applications. They are available in two configurations: - Standard enteral extension sets, with a variation in tube length and diameter - Bifurcated extension sets, which allow for medication or additional delivery without disrupting the feeding line with a variation in tube length Enteral Extension Sets consists of flexible tubing with a purple strip on the tubing. The enteral connectors are purple in color for ease of identification of enteral feeding lines. The female connector has a tethered cap to cover the connector when not used to prevent fluid leakage. A clamp is present over the tube to stop the fluid flow as needed. Transitional Adapters allow for the connection of RightFit Enteral Extension Sets to non-enteral systems. The Transitional Adapters are available in two configurations: - Enteral female to enteral female - Enteral male to enteral male
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