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510(k) Data Aggregation

    K Number
    K232165
    Device Name
    Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
    Manufacturer
    Berpu Medical Technology Co., Ltd.
    Date Cleared
    2024-02-01

    (195 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Berpu Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Safety Hypodermic Needles for Single Use are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. The Sterile Hypodermic Needles for Single Use- Disposable Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration. The Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles are intended to be used with a luer slip or luer lock syringes and injection devices for general purpose fluid injection/aspiration.
    Device Description
    The proposed devices are provided in two types of configurations; one type is a Sterile Safety Hypodermic Needles for Single Use, the other is Sterile Hypodermic Needles for Single Use. The Sterile Hypodermic Needles also divided into two types, one type is an ordinary disposable needle contained in a sterility maintenance package, the other is self-sealing hypodermic needle with an end cap, the protective cap and end cap form a sterility maintenance package. The Sterile Safety Hypodermic Needles for Single Use are intended for single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub. The proposed device is available in 28-34 gauge and 4-32 mm lengths. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Hypodermic Needles for Single Use are intended for single use only. The proposed device is available in 18-34 gauge and 2-40 mm lengths. The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and are supplied in a sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
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    K Number
    K220061
    Device Name
    Safety Insulin Syringes
    Manufacturer
    Berpu Medical Technology Co., Ltd.
    Date Cleared
    2022-08-23

    (225 days)

    Product Code
    MEG, FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Berpu Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
    Device Description
    The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
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    K Number
    K213158
    Device Name
    Syringe with permanently attached needle
    Manufacturer
    Berpu Medical Technology Co., Ltd.
    Date Cleared
    2022-07-21

    (296 days)

    Product Code
    FMF, MEG
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Berpu Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
    Device Description
    The Syringe with permanently attached needle is intended for single use only. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 20G-34G gauge needle. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. The proposed syringes are available in different combination of syringe volumes and/or needle sizes.
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    K Number
    K213811
    Device Name
    Sterile Hypodermic Syringes for Single Use
    Manufacturer
    Berpu Medical Technology Co., Ltd.
    Date Cleared
    2022-05-12

    (156 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Berpu Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purposes on adult and pediatric population to inject fluids into or withdraw fluids from the body.
    Device Description
    The Sterile Hypodermic Syringe for Single Use is intended for single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle.
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    K Number
    K212514
    Device Name
    Safety Pen Needle for Single Use, Insulin Pen Needles
    Manufacturer
    Berpu Medical Technology Co., Ltd.
    Date Cleared
    2022-04-29

    (262 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Berpu Medical Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin.
    Device Description
    The devices are provided in two types of configurations: Safety Pen Needle for Single Use and Insulin Pen Needle. The Safety Pen Needle for Single Use is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of a needle cap, needle hub, safety protective cover, self-destruction seat and sealed paper. The safety protective cover is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. It consists of protective cap, needle tube, needle protective cover and sealed paper.
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