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510(k) Data Aggregation

    K Number
    K223645
    Device Name
    I.V. Administration Set, I.V. Extension Set
    Date Cleared
    2023-05-18

    (163 days)

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

    BQ PLUS Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 in delivering intravenous fluids from a container to patient.
    Device Description
    The subject device is a single use device. It has ten models and their features are listed in Table 1. The ten models have differences in configurations. The differences are provided in Table 2. The I.V. Administration Set is used 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 in delivering intravenous fluids from a container to patient. There are ten different models, each configuration containing various components which may include: Spike Protector, Vented Air Cap, Air Filter, Spike, Drip Chamber, 10 Drops, Tubing, Back Check Valve, Needle Free TYPE Y, Clamp, Roller, Precision Filter, Robert Clamp, Male Luer Slip, Luer Lock Ring, Protective Cap, 15um Filter, Flow Regulator, Female Luer Connector. The devices are provided sterile and single use.
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    K Number
    K210381
    Device Name
    I.V. Administration Set
    Date Cleared
    2021-08-14

    (186 days)

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

    BQ PLUS Medical Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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.
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