Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K210381
    Device Name
    I.V. Administration Set
    Manufacturer
    BQ PLUS Medical Co., Ltd.
    Date Cleared
    2021-08-14

    (186 days)

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

    BQ PLUS Medical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The I.V. Administration Set intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. The I.V. Extension Set may act as an extension of other infusion tubing intravenous fluids from a container to patient.
    Device Description
    The propose device, I.V. Administration Set, is a single used device. It has seven models. The models and their features are listed in Table 1. There are seven different models, each configuration comprise of various components which may include: IV Chamber, Tubing, Roller Clamp, Y Site, Needle Free Valve, Slide Clamp, Back Check Valve, Male Luer Lock, 3 Way Stop Cock, Female Luer Lock, Flow Regulator, Rotating Luer Lock, T-Connector, Luer Lock Cap, Hanger, Drop, Female Luer Connector and Cap. The devices are provided sterile and single use. The proposed devices are sterilized by EO to achieve a SAL 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 3 years.
    Ask a Question

    Page 1 of 1