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510(k) Data Aggregation

    K Number
    K212019
    Device Name
    Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd
    Date Cleared
    2021-11-04

    (129 days)

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

    Jiangsu Micsafe Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    (1) Blood Collection Needle for Single Use The Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (2) Safety Blood Collection Needle for Single Use The Safety Blood Collection Needle for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (3) Blood Collection Needle with Holder for Single Use The Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (4) Safety Blood Collection Needle with Holder for Single Use The Safety Blood Collection Needle with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (5) Blood Collection Set for Single Use The Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (6) Safety Blood Collection Set for Single Use The Safety Blood Collection Set for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (7) Blood Collection Set with Holder for Single Use The Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. (8) Safety Blood Collection Set with Holder for Single Use The Safety Blood Collection Set with Holder for Single Use is intended to be used with vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
    Device Description
    The subject devices are single use, EtO sterilized with a shelf-life of 5 years. Blood collection needles and holders are intended to be used with a vacuum blood collection tube for multiple collections of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury. (1) Blood Collection Needle for Single Use This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube and needle sleeve. (2) Safety Blood Collection Needle for Single Use This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve. (3) Blood Collection Needle with Holder for Single Use This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, needle sleeve, holder. (4) Safety Blood Collection Needle with Holder for Single Use This product use PP, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub with safety shield, needle tube, needle sleeve, holder. (5) Blood Collection Set for Single Use The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve. (6) Safety Blood Collection Set for Single Use The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, safety shield, needle tube, tube, tubing, butterfly wings, needle sleeve. (7) Blood Collection Set with Holder for Single Use The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, needle tube, tubing, butterfly wings, needle sleeve, holder. (8) Safety Blood Collection Set with Holder for Single Use The products use PP, ABS, PVC, Polyisoprene rubber and SUS304 as the main materials. It contains needle cap, needle hub, safety shield, needle tube, tubing, butterfly wings, needle sleeve, holder.
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    K Number
    K202570
    Device Name
    Insulin Syringe, Insulin Syringe with Safety Retractable
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd
    Date Cleared
    2021-07-02

    (301 days)

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

    Jiangsu Micsafe Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insulin Syringe is a sterile, single use and non-reusable, insulin syringe intended for injection of U-100 insulin into the body. The Insulin Syringe with Safety Retractable is a sterile, single use and non-reusable, manual retractable safety insulin 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
    (1) Insulin Syringe This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube and needle cap. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d). (2) Insulin Syringe with Safety Retractable This product uses PP, Polyisoprene rubber and SUS304 as the main materials. It consists of barrel, plunger, plunger stopper, needle tube, safety shield and needle cap. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. Product Contact Classification: Externally Communicating, Blood Path and Tissue Contact with prolonged contact duration (>24 h to 30 d).
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    K Number
    K202205
    Device Name
    Surgical Face Mask
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd
    Date Cleared
    2021-03-09

    (216 days)

    Product Code
    FXX
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Jiangsu Micsafe Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Surgical Face Mask is intended to be worn to protect both the patient and healthcare persomel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce potential exposure to blood and body fluids. The face mask is single use, disposable device, provided nonsterile.
    Device Description
    The Surgical Face Mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Surgical Face Mask around the nose. The Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H- phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8), and the middle layer is made of Melt blown polypropylene filter. Ear loops, which is held to cover the users' mouth and nose by two Spandex elastic cord and chinlon ultrasonic welded to the Surgical Face Mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Surgical Face Mask is in the middle layer of Surgical Face Mask to allow the user to fit the Surgical Face Mask around their noses, which is made of steel wire and polypropylene. The Surgical Face Mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Surgical Face Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 115±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
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    K Number
    K183665
    Device Name
    Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd.
    Date Cleared
    2019-09-06

    (253 days)

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

    Jiangsu Micsafe Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Safety Needles: The safety needles 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. Sterile Syringe: The sterile syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. Sterile Syringe with Safety Needle: The sterile 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. Sterile Syringe with Needle: The sterile syringe with needle is intended for use the aspiration of fluids for medical purpose. Hypodermic Needles for Single Use: The hypodermic needle is intended to be used with a luer slip or luer lock syringe for aspiration of fluids for medical purpose.
    Device Description
    (1)Safety Needles: The Safety Needles are intended for manual and single use only. They consist of a needle cap, needle tube and hub with protector. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. (2)Sterile Syringe: The Sterile Syringe is intended for manual and single use only. It consists of a Barrel, Plunger, and Piston. The syringes are available with luer slip and luer lock connector types and are available in different sizes. They are intended to be connected to a safety/hypodermic needle. (3)Sterile Syringe with Safety Needle: This product is intended for manual and single use only. The Sterile Syringe with Safety Needle consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. (4)Sterile Syringe with Needle: The Sterile Syringe with Needle is intended for manual and single use only. It consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety of syringe and needle sizes. (5)Hypodermic Needles for Single Use: The Hypodermic Needle is intended for manual and single use only. It consists of a hub, needle tube, needle cap. The proposed device is compatible for use with a luer slip or luer lock syringe.
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    K Number
    K181426
    Device Name
    Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL)
    Manufacturer
    Jiangsu Micsafe Medical Technology Co., Ltd
    Date Cleared
    2018-10-11

    (133 days)

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

    Jiangsu Micsafe Medical Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject device is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.
    Device Description
    Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) are basically enteral syringes that can also be used for oral uses. There are two different types of models of the syringes, which are Type A and Type B. The Type A syringes of a polypropylene barrel and plunger rod and a synthetic rubber gasket stopper manufactured from polyisoprene. The Type B syringes consist of a polypropylene barrel and plunger rod and a silicone O-ring. The 10 to 60 mL syringes come with the standard female ENFit connector and the 1 to 5 mL syringes come with a female ENFit connector incorporating a low dose tip design.
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