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510(k) Data Aggregation

    K Number
    K231707
    Device Name
    ResQ Administration Set
    Date Cleared
    2024-01-03

    (205 days)

    Product Code
    Regulation Number
    880.5440
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    Applicant Name (Manufacturer) :

    Q for Plastic Industries

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings.
    Device Description
    ResO Administration set is a single use, gravity feed, sterile device sterilized with Ethylene Oxide Gas. ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings. ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications. The proposed device consists of protective cap, air filtration membrane, closure-piercing device, drip chamber, medicine fluid filter, roller clamp, tubing, flow regulator, injection sites (needle access - needleless access), in-line filter &two-part luer lock connector. The protective cap is intended to maintain sterility and to protect the closure piercing device that used to pierce the container, the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution, the roller clamp is used to control the flow of the medicine solution, the tubing is used to connect various components, the flow regulator is used to adjust the flow rate from zero to maximum, there are two injection sites one is needleless and the other is needle access, which are used to inject solution into the tubing, the in-line filter used for retention of particles, bacteria and fungi, also it used for elimination of the air, two-part luer lock connector is used to connect the infusion needle or catheter with the tubing. - It is single use device, sterilized by EO sterilization. ● - . Environment of Use: healthcare facility/hospital
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