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510(k) Data Aggregation

    K Number
    K222766
    Device Name
    Disposable Extension Set
    Date Cleared
    2024-04-12

    (577 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shandong Ande Healthcare Apparatus Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device. The intended populations include adults and pediatrics except neonates.
    Device Description
    The proposed device is a single used device. It includes 30 models. For the 30 different models, each configuration comprises of various components which may include: Male luer lock and protector, Female luer lock and protector. Tube, Flow regulator, Clamp, multiple ways connector, Precision Liquid filter, Needle free connector, Check valve, Graduated flow regulator. Injection site and stopcock. The detail description of models is provided in Table 1. The proposed devices are sterilized by EO to achieve a SAL 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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