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510(k) Data Aggregation

    K Number
    K222246
    Device Name
    Disposable Sterile Lancet
    Manufacturer
    Tianjin Rilifine Medical Device Co., Ltd.
    Date Cleared
    2022-11-21

    (118 days)

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

    Tianjin Rilifine Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Disposable Sterile Lancet: The lancet is intended for capillary blood sampling. Lancing Device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.
    Device Description
    Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850). The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device. The intended users include healthcare personnel, patients and lay users. The lancet is provided sterile. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the lancet is 5 years.
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    K Number
    K222055
    Device Name
    Disposable Sterile Lancet
    Manufacturer
    Tianjin Rilifine Medical Device Co., Ltd.
    Date Cleared
    2022-11-15

    (126 days)

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

    Tianjin Rilifine Medical Device Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    It is intended for capillary blood sampling.
    Device Description
    Disposable Sterile Lancet is Class II Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature bearing the product code FMK (21CFR878.4850). The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. The Disposable Sterile Lancet consist of protective cap, housing, bottom, fire button, connection ring, springs (ejection spring and fire spring), and core of lancet (including needle). The sterile part of the lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf life of the product is 5 years.
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