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    K Number
    K222408
    Device Name
    Disposable Safety Lancet
    Manufacturer
    Beijing Ruicheng Medical Supplies Co., Ltd.
    Date Cleared
    2022-11-29

    (111 days)

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

    Beijing Ruicheng Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Disposable Safety Lancet is intended for capillary blood sampling.
    Device Description
    The Disposable Safety Lancet is intended for capillary blood sampling. The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1. The models include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G. Disposable Safety Lancet are spring-loaded lancet. Disposable Safety Lancet are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.
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    K Number
    K222034
    Device Name
    RightLance Blood Lancing System
    Manufacturer
    Beijing Ruicheng Medical Supplies Co., Ltd.
    Date Cleared
    2022-09-07

    (58 days)

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

    Beijing Ruicheng Medical Supplies Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
    Device Description
    The proposed device, RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm. The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of. This system is for use only on a single patient in a home setting. This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting. The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet. The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19 The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G
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