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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?
    Product Code :

    LKB

    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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    K Number
    K121655
    Device Name
    BD ALCOHOL SWAB
    Manufacturer
    BECTON DICKINSON & CO.
    Date Cleared
    2013-03-20

    (288 days)

    Product Code
    LKB
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BD Alcohol Swab is a single use, sterile device containing 70% Isopropyl alcohol. When used for scrubbing for 5 seconds and allowing drying for 5 seconds, the BD Alcohol Swab disinfects needleless access sites prior to use. It may be used in the home or healthcare facility.
    Device Description
    The BD Alcohol Swab is a single use, sterile device that is saturated with 70% USP grade Isopropyl alcohol and intended to for needleless access site disinfection.
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    K Number
    K112791
    Device Name
    SITESCRUB IPA DEVICE
    Manufacturer
    CR BARD
    Date Cleared
    2012-02-24

    (151 days)

    Product Code
    LKB
    Regulation Number
    N/A
    Why did this record match?
    Product Code :

    LKB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Site-Scrub IPA Device is intended for use on injection ports and female luer hubs as a disinfecting cleaner.
    Device Description
    The subject Site-Scrub IPA Device is a handheld, sterile, single use device containing isopropyl alcohol (IPA) 70% (v/v) solution. The Site-Scrub IPA Device, by design, provides active mechanical friction and IPA to clean and disinfect surfaces, such as injection ports and female luer hubs, in accordance with 2011 CDC guidelines that recommend for needleless intravascular catheter systems that contamination be minimized by "scrubbing the access port with an appropriate antiseptic (including 70% alcohol) and accessing the port only with sterile devices." The foam design allows for application of the IPA on internal and external surfaces. The Site-Scrub IPA Device has been specifically designed to disinfect female luer hubs and injection ports and has undergone in vitro testing to validate its effectiveness for this purpose. The results of in vitro antimicrobial efficacy testing show the Site-Scrub IPA Device is effective, when used as intended, for significantly reducing (> 4 Log10 or 99.99% reduction) microbial load of the following microbes known to be associated with catheter line-associated blood stream infections (CLABSI) which include: 1. Candida albicans, 2. Candida parapsilosis, 3. Escherichia coli, 4. Pseudomonas aeruginosa, 5. Staphylococcus aureus (MRSA), and 6. Staphylococcus epidermidis (MRSE).
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