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510(k) Data Aggregation

    K Number
    K212846
    Device Name
    Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use
    Date Cleared
    2022-08-30

    (357 days)

    Product Code
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Jichun Medical Devices Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sterile Hypodermic Syringe for Single Use, with/without needle: The sterile hypodermic syringe for single use, with/without needle is intended for use in the aspiration of fluids for medical purposes. Sterile Hypodermic Needle for Single use: The sterile hypodermic needle for single use is intended for use with syringes in the aspiration of fluids for medical purposes.
    Device Description
    Sterile Hypodermic Syringe for Single Use, with/without needle: The sterile hypodermic syringe for single use, with/without needle is intended for used in the aspiration and injection of fluids for medical purposes. Sterile Hypodermic Needle for Single use: The sterile hypodermic needle for single use is intended for use with syringes in the aspiration and injection of fluids for medical purposes. The device is delivered in the following configurations: Needle Gauge: 18,19,20,21,22,23,24,25,26,27,28,29,30G Needle Length: 1/6"-1 1/2" Syringe Volume: 1,2,3,5,10,20,30,50,60,100 ml Sterile Hypodermic Syringe for Single Use, with/without needle and Sterile Hypodermic Needle for Single use materials are as noted in the table below: Needle cap: PP Needle tube: Stainless Steel Needle hub: PP Barrel: PP Plunger stopper: Isoprene rubber Plunger: PP Ink: Black Lubricant: Silicone oil Adhesive: Epoxy resin Colorant: PP masterbatch The contact level of the subject device is blood path, indirect, and the contact duration is limited contact (<24 hours).
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