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510(k) Data Aggregation

    K Number
    K211025
    Device Name
    Oral/Enteral Syringe with ENFit connector
    Manufacturer
    Ningbo Tianyi Medical Appliance Co., Ltd.
    Date Cleared
    2021-06-30

    (85 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Tianyi Medical Appliance Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
    Device Description
    The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. It consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male ENFit connector. The syringes (size 12ml, 35ml and 60ml) incorporate a female Standard ENFit connector; the syringes (size 0.5ml, 1ml, 3ml, 6ml) incorporate a female low dosing ENFit connector. There are 2 types of the syringe: Side connector ENFit syringe and central connector ENFit syringe. The sizes of the central connector tapered syringe range from 0.5ml and 1ml; and side connector ENFit syringe range from 3ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
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    K Number
    K210621
    Device Name
    Oral/Enteral Syringe
    Manufacturer
    Ningbo Tianyi Medical Appliance Co., Ltd.
    Date Cleared
    2021-04-28

    (57 days)

    Product Code
    PNR
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ningbo Tianyi Medical Appliance Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a dispenser, a measuring device and an oral fluid transfer device. It is intended to be used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by operators ranging from qualified medical practitioners to laypersons (under the supervision of a qualified medical practitioners) in all age groups.
    Device Description
    The proposed device is a disposable enteral feeding syringe provided in a variety of sizes from 0.5ml to 60ml. The enteral feeding syringe consists of plunger, piston, barrel and tip cap, and used to deliver fluids into the body orally or connected to an enteral access device with male tapered connector. There are 2 types of the syringe: Side connector tapered syringe and central connector tapered syringe. The sizes of the central connector tapered syringe range from 0.5ml to 3ml; and side connector tapered syringe range from 6ml to 60ml. The proposed syringe is sterile or non-sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of three years.
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