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510(k) Data Aggregation

    K Number
    K212652
    Device Name
    Sterile Syringe with Fixed Safety Needle for Single Use
    Manufacturer
    Gemtier Medical (Shanghai) Inc.
    Date Cleared
    2022-03-02

    (191 days)

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

    Gemtier Medical (Shanghai) Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Syringe with Fixed Safety Needle for Single Use is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety mechanism can be manually activated to cover the needle immediately to minimize risk of accidental needlesticks.
    Device Description
    Sterile Syringe with Fixed 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 and fixed needle with a safety mechanism. 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. The proposed device is available in a variety combination of syringe volume and needle size. | Syringe volume | Needle Gauge | Length | Wall type | |----------------|--------------|----------|-----------| | 1ml | 21G | 5/8", 1" | TW | | 1ml | 22G | 5/8", 1" | TW | | 1ml | 23G | 5/8", 1" | TW | | 1ml | 25G | 5/8", 1" | RW |
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    K Number
    K192679
    Device Name
    Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
    Manufacturer
    Gemtier Medical (Shanghai) Inc.
    Date Cleared
    2020-04-10

    (197 days)

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

    Gemtier Medical (Shanghai) Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sterile Syringe with Safety needle for Single Use in the aspiration and injection of fluids for medical purpose. 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. Sterile Syringe for Single Use is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. Sterile Safety Needle for Single Use is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. 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.
    Device Description
    Sterile 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. The Sterile Syringe for Single Use 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, which is intended to be connected with a hypodermic needle. Sterile 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 needle tube, retractable cartridge, jointing medium and needle hub. The proposed device is available in variety of needle gauge and needle length. According to the needle length, the safety mechanism is available in 2-part cartridge (outer retractable cartridge and inner retractable cartridge) and 3-part cartridge (outer retractable cartridge, middle retractable cartridge and inner retractable cartridge). The proposed device is compatible for use with a 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.
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    K Number
    K170276
    Device Name
    Safety Blood Collection Device for Single Use
    Manufacturer
    Gemtier Medical (Shanghai) Inc.
    Date Cleared
    2017-12-11

    (315 days)

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

    Gemtier Medical (Shanghai) Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is a single-use, sterile, winged venipuncture needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The SAFETY BLOOD COLLECTION DEVCIE FOR SINGLE USE is used for blood collection and/or the short-term infusion of intravenous fluids (up to 2 hours under direct clinical supervision). The venipuncture needle is designed to be covered with a safety mechanism, which can be activated to cover needle immediately following venipuncture to aid in the protection against accidental needlestick injury.
    Device Description
    The Safety Blood Collection Device for Single Use is a single-use, sterile, winged blood collection needle bonded to a flexible tubing with or without a luer adapter and/or tube holder. The Safety Blood Collection/Infusion Set is individually wrapped, sterile, non-pyrogenic and is designed for collection of blood specimens or short-term intravenous administration of fluid (up to 2 hours under direct clinical supervision). When it's equipped with male luer adapter and/ or tube holder, it can be used for taking samples from the patients through vacuum tubes. It is also indicated for short-term intravenous fluids (up to 2 hours under direct clinical supervision) after attaching to an IV set, a transfusion set or to other compatible/appropriate device. Three models were included in this submission, which are JT-HSQ, JT-HSQ-B, and JT-HSQ-Z.
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