LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140623
    Device Name
    NXSTAGE EXPRESS FLUID WARMER
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Date Cleared
    2014-06-16

    (97 days)

    Product Code
    FLA
    Regulation Number
    876.5820
    Why did this record match?
    Product Code :

    FLA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NxStage Express Fluid Warmer and Express Fluid Warmer Disposable Set are accessories to the NxStage System One Cycler used to warm dialysate prior to administration.
    Device Description
    The NxStage Express Fluid Warmer is an accessory to the NxStage System One used to warm dialysate prior to administration. The Express Fluid Warmer is for use with the NxStage System One only and is not used to warm blood or blood products. The Express Fluid Warmer consists of an electro-mechanical warming unit and a single-use disposable.
    Ask a Question

    Page 1 of 1