BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub

    K Number: K213955 · Decision Jul 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    134
    Review Days
    211

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    Basic Information

    Device Name
    0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub
    K Number
    K213955
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Becton, Dickinson and Company
    Date Received
    December 17, 2021
    Decision Date
    July 16, 2022
    Product Code
    QTI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QTI Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

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