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510(k) Data Aggregation

    K Number
    K223314
    Device Name
    Disposable Blood Lancets
    Date Cleared
    2023-01-25

    (89 days)

    Product Code
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
    Device Description
    The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.
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    K Number
    K223313
    Device Name
    Disposable Safety Lancets
    Date Cleared
    2023-01-23

    (87 days)

    Product Code
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The product is used to obtain capillary blood samples from fingertip in a home. The device contains a sharp injury protection feature.
    Device Description
    The Disposable Safety Lancets consists 7 parts, include a trigger, plastic handle, out shell, back cover, spring, protective cap and needle. The models of the Disposable Safety Lancets are 21G; 23G; 26G; 28G; 30G. The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The device contains a sharp injury feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. And once activated, the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. Used Gamma sterilization, and are products for single use.
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