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510(k) Data Aggregation

    K Number
    K232881
    Device Name
    Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd
    Date Cleared
    2023-12-22

    (95 days)

    Product Code
    JKA, FMI, FPA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Kangbao Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Winged Infusion Set is indicated for the short-term infusion of intravenous fluids for 2 hours or less. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Blood Collection Set with Holder is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. Safety Blood Collection Set is indicated for venous blood collection. It is to be used by appropriately trained healthcare professionals in accordance with the instructions. The safety shield is intended to aid in the protection against accidental needle stick injury. Safety Blood Collection set with Holder is indicated for venous blood collection. It is to be used by trained healthcare professionals in accordance with the instructions. The safety shield to aid in the protection agamst accidental needle stick injury. Needle Holder is used for the collection of blood specimen into the blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. It is to be used by trained healthcare professional only.
    Device Description
    The Blood Collection Set with Holder, Blood Collection Set, and Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector. The devices are individually wrapped and sterile with a luer port. The luer port can connect FDAcleared accessories like luer adapter, holder, etc. The Safety Blood Collection Set with Holder, Safety Blood Collection Set, and Safety Winged Infusion Set are single-use, sterile, winged needles bonded to flexible tubing with a Luer connector and a safety mechanism. The winged needle is designed with a safety mechanism, which allows for activation and ensures the needle is covered immediately following venipuncture to protect against accidental needlestick injury. The Safety Blood Collection / Infusion Set (with/without needle holder) is individually wrapped sterile with a luer port. The luer port can connect FDA-cleared accessories like luer adapter, holder, etc. The safety feature is operated by releasing a latch mechanism whereby the user slides a winged cover over the needle as it is removed from the patient. Once the needle is covered, the safety cover locks in place. There is no ability to clean and reuse these because the safety feature cannot be deactivated without bending the needle and rendering it unusable. The devices are used for venous blood collection and/or the short-term infusion of intravenous fluids. The product is to be used by appropriately trained healthcare professionals only in accordance with the manufacturer's instructions. It can be used with an intravascular administration set, syringe, or other device to administer fluids.
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    K Number
    K221247
    Device Name
    Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd.
    Date Cleared
    2022-11-01

    (183 days)

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

    Jiangsu Kangbao Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration 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 needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Sterile Disposable Safety Needle is 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 safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
    Device Description
    The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle gauges and lengths. The safety needle is compatible for use with a luer slip and luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Needle specification is same as the needle size of Sterile Disposable Syringe with Safety Needle. Compared with Sterile Disposable Safety Needle, Sterile Disposable Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose. There are two kinds of sterile disposable syringe with safety needle: syringe with fixed needles and syringe without fixed needles. Sterile disposable syringe with safety needle of 0.5ml and 1ml are available syringe with fixed needles. Syringe without fixing needle are consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size. Compared with Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Needle do not have a type of the syringe with fixed needle. The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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    K Number
    K211329
    Device Name
    Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd
    Date Cleared
    2021-11-15

    (196 days)

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

    Jiangsu Kangbao Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration 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 needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Sterile Disposable Syringe is a sterile luer slip or luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. The Sterile Disposable Safety Needle is intended to be used with a luer slip or 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 needle sticks. The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose.
    Device Description
    The Sterile Disposable Syringe is intended for manual and single use only, which consists of piston, barrel, and plunger. The proposed device is available in a variety syringe volume. The syringe is available in luer lock and luer slip configurations, which are intended to be connected with a hypodermic needle. The Sterile Disposable Safety Needle is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of needle tube, needle hub and safety mechanism. The proposed device is available in variety of needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. Compared with The Sterile Disposable Safety Needle, The Sterile Disposable Needle has the same components and specifications except without safety mechanism. The Sterile Disposable Syringe with Safety Needle for Single Use is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of syringe (piston, barrel, plunger) and hypodermic needle with a safety mechanism. The proposed device is available in a variety combination of syringe volume and needle size. Compared with The Sterile Disposable Syringe with Safety Needle, The Sterile Disposable Syringe with Needle has the same components and specifications except without safety mechanism. The proposed devices are sterilized by Ethylene Oxide a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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    K Number
    K192681
    Device Name
    Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type)
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd.
    Date Cleared
    2020-07-28

    (306 days)

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

    Jiangsu Kangbao Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vein set is intended for vein puncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy Safety vein set is intended for vein puncture to collect blood specimens. It is also indicated for intravenous administration of fluids after removing the attached luer adapter from the blood collection set connector and attaching a syringe, or other compatible/appropriate device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick. Blood collection needle (vein set type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. Blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. Safety blood collection needle (vein set type) is intended for use in the blood collection or short-term influsion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce the risk injury. Safety blood collection needle (needle holder type) is intended for use in the blood collection or short-term infusion (up to 2 hours) of intravenous fluids. The device is designed with a safety mechanism to help reduce stick injury
    Device Description
    The proposed device is a blood collection device that forms a passage between the patient's vein and a vacuum blood collection tube for collecting blood. The proposed device can also be used for short-term infusion. The proposed devices are divided into several types, some have safety devices and some do not have safety devices, and the safety mechanism helps to reduce the risk of needle stick injuries. The proposed devices are provided sterile, single use. The propose device can be used for vein collect blood/infusion as well as peripheral vein collect blood/infusion, but not central vein collect blood/infusion.
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    K Number
    K182649
    Device Name
    Enteral Feeding Syringes with Enfit Connectors
    Manufacturer
    Jiangsu Kangbao Medical Equipment Co., Ltd
    Date Cleared
    2018-11-09

    (46 days)

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

    Jiangsu Kangbao Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Enteral Feeding Syringe with ENFit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral syringes are intended to be used in clinical or home care settings by users ranging from laypersons (under the supervision of a clinician) to clinicians in all age groups.
    Device Description
    The proposed device, Enteral Feeding Syringes with ENfit Connectors, is provided sterile, single use. It has 3 components: (1) barrel, (2) plunger, and (3) piston. The Enteral Feeding Syringes with ENfit Connectors is available in various size, including 1ml, 2.5ml, 5ml, 10ml, 20ml, 60ml and 100ml. In addition, it contains low dose enteral specific connectors. The Enteral Feeding Syringes with ENfit Connectors is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
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