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510(k) Data Aggregation

    K Number
    K241750
    Device Name
    Medifun Safety Lancet ( MSL1 series)
    Manufacturer
    Medifun Corporation
    Date Cleared
    2024-08-15

    (58 days)

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

    Medifun Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safety lancet is intended for capillary blood sampling.
    Device Description
    The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective cap. The sterile part of the safety 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. The lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.
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    K Number
    K231797
    Device Name
    Medifun Lancing Device, Model No. LD-E1
    Manufacturer
    Medifun Corporation
    Date Cleared
    2023-11-22

    (155 days)

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

    Medifun Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
    Device Description
    Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.
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