Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K082858
    Device Name
    EXSEPT WC ANTIMICROBIAL SKIN AND WOUND CLEANSER
    Manufacturer
    ALCAVIS INTERNATIONAL, INC.
    Date Cleared
    2009-05-27

    (240 days)

    Product Code
    FQH
    Regulation Number
    880.5475
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCAVIS INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OTC: ExSept WC Skin and Wound Cleanser is intended for cleansing and removal of dirt, debris and foreign material from minor skin abrasions, minor lacerations, minor irritations, minor cuts, and intact skin. Professional Use: Under supervision of healthcare professionals, ExSept WC Skin and Wound Cleanser is intended for use for mechanical cleansing, debridement and removal of foreign material and debris from exudating and/or dirty wounds, such as stage I-IV pressure ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites, and catheter exit sites.
    Device Description
    ExSept WC Skin and Wound Cleanser is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and 100 ml, 250 ml and 500 ml pour bottles. ExSept WC Skin and Wound Cleanser has a 30 month shelf life.
    Ask a Question
    K Number
    K061467
    Device Name
    EXSEPT WC WOUND CLEANSER
    Manufacturer
    ALCAVIS INTERNATIONAL, INC.
    Date Cleared
    2007-02-15

    (265 days)

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

    ALCAVIS INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For debridement and the removal of foreign material and debris from exudating and/or dirty wounds, abrasions and minor irritations, cuts, exit sites, and intact skin.
    Device Description
    ExSept WC is a clear to slight yellow, slight chlorine odor, solution which is intended for the mechanical cleansing of debris and foreign material from exudating/dirty epidermal and dermal wounds. It is supplied in a 200 ml pump-spray and a 100 ml, 250 ml, and 500 ml pour white, opaque, bottles. ExSept WC has a shelf-life of 30 months.
    Ask a Question
    K Number
    K043126
    Device Name
    ASSIST HEADER CLEANER
    Manufacturer
    ALCAVIS INTERNATIONAL, INC.
    Date Cleared
    2005-02-03

    (83 days)

    Product Code
    LIF
    Regulation Number
    876.5820
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALCAVIS INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To aid in the cleaning of the headers, header spaces, and header caps of multiple-use hemodialyzers prior to an approved reprocessing procedure for reusable hemodialyzers.
    Device Description
    The ASSIST Header Cleaner™ is a one-piece device used to assist with the manual cleaning of headers in reusable hemodialyzers. One end of the ASSIST unit is inserted and attached to the arterial blood port on the header cap. The other end of the ASSIST unit is connected to a supply of reverse osmosis water. Jets of RO water are sprayed inside of the header to break up and clear away any debris, including clotted blood, in the header space. The dialyzer is manually turned along its longitudinal axis during this process to allow the water jets to contact all side surfaces of the header. This operation is repeated on the venous end where, besides cleaning, the water is used to flush the blood/debris/water mixture from the arterial end of the dialyzer. The dialyzer is flipped again and the process is repeated for a second time at the arterial end to flush away any blood/debris/water mixture from the venous end of the dialyzer.
    Ask a Question

    Page 1 of 1