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510(k) Data Aggregation

    K Number
    K132380
    Device Name
    PREVANTICS DEVICE SWAB
    Manufacturer
    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.
    Date Cleared
    2014-08-27

    (392 days)

    Product Code
    LKB
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    PROFESSIONAL DISPOSABLES INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Prevantics® Device swab contains a 3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol swab is intended for use to disinfect needleless access sites prior to use.
    Device Description
    The Prevantics® Device swab is available as a 2 in. x 2 in. swab which contains a 1mL solution (3.15% Chlorhexidine Gluconate and 70% (v/v) Isopropyl Alcohol). The product is intended for single, non-sterile use and is not made with natural rubber latex. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devises.
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