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510(k) Data Aggregation

    K Number
    K060141
    Device Name
    DAI-R
    Manufacturer
    Date Cleared
    2006-06-12

    (144 days)

    Product Code
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHL MEDICAL, USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The DAI-R™ Autoinjector is a hand-held mechanical device intended for the automated, selfadministration of FDA-approved drugs and biologics. The DAI-R™ Autoinjector is designed to be used with a standard Glass Barrel 1mL Long Syringe with Luer Lock Tip that has been prefilled prior to an injection. The DAI-R™ Autoinjector is for use in the home environment to aid and support prescribed treatment and therapy.
    Device Description
    The DAI-R is an automatic drug delivery device that is used for the injection of drugs and biologics from standard Glass Barrel 1mL Long syringes with Luer Lock Tip that have been prefilled prior to use in the DAI-R. The DAI-R is a single-use, disposable, syringe needle introducer device. It is spring-powered and designed to administer the entire contents of the prefilled syringe in one dose. The DAI-R injection has three operational steps: 1) the automatic insertion of the syringe needle to a predetermined depth into the body, 2) the automatic delivery of the syringe contents, and 3) the withdrawal of the needle from the body. The DAI-R consists of a main body and a syringe carrier assembly. The syringe carrier is used to load the prefilled syringe into the main body to make a complete DAI-R delivery system. The complete DAI-R is a plastic tube with the loaded prefilled syringe, a front needle shield and a rear power assembly. The components of DAI-R are made of plastic and steel. The DAI-R does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
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    K Number
    K050434
    Device Name
    SHL DISPOSABLE AUTOINJECTOR
    Manufacturer
    Date Cleared
    2005-06-24

    (122 days)

    Product Code
    Regulation Number
    880.6920
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHL MEDICAL, USA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    DAI™ is a hand-held mechanical device intended for the automated, subcutaneous, selfadministration of FDA-approved drugs and biologics. DAI™ is designed to be used with the standard 1.0mL Long (glass) Syringe with Needle that has been prefilled prior to an injection. DAI™ is for use in the home environment to aid and support prescribed treatment and therapy.
    Device Description
    DAI™ is an automatic drug delivery device that is used for the subcutaneous administration of drugs and biologics from standard 1.0mL long glass syringes with staked needle from 25g to 27g and 12.7mm in length that are prefilled prior to use in DAI™ is a single-use, disposable, syringe needle introducer device that is spring-powered and designed to administer the entire contents of the prefilled syringe during one injection. A DAI™ injection consists of the automatic insertion of the syringe needle to a predetermined depth into the skin, followed by the automatic delivery of the syringe contents. DAT™ consists of two subassemblies into which the syringe is loaded and connected together to form the delivery system for self injection. The assembled DAI has a tubular design with a needle end and a power assembly with activation button end. DAI™ components and subassemblies are made of plastic and metal. DAI™ does not have any fluid path and does not have any contact with the drug or biologic contained within the syringe.
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