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510(k) Data Aggregation

    K Number
    K222834
    Device Name
    Safety Push Button Blood Collection Set
    Date Cleared
    2023-01-05

    (107 days)

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

    Jiangsu Caina Medical Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Safety Push Button Blood Collection Set is intended to be used for insertion into a patient's vascular system for blood specimens. When used without the male adapter, the device allows the clinician to obtain blood sampling from the female hub with a syringe, if necessary, or can be used for short-term (up to 2 hours), single infusions with consideration given to patient size and appropriateness for the solution being infused. The device is not to be left in place and remain under the direct supervision of a clinician. It aids in the prevention of accidental needle stick through the use of an active safety feature. The device is a sterile, multiple sample, single-use.
    Device Description
    The proposed device consists of these components: (1) Needle, (3) Spring, (4) Butterfly wings, (5) Hub, (6) Safety sheath, (7) Flexible tube, (8) Female luer, (9) Male luer hub, (10) Puncture needle, (11) Rubber sleeve, (12) Puncture needle protect cover or holder, (13) Safety push button protect cover. The proposed device have three configurations: With holder, With holder, Without male adapter. For without male adapter, there is a a protective cap to cover female luer. The proposed device is available various needle size and tube length. The range of needle size is from 25G(0.5mm). The range of tube length is from 10cm(4") to 30cm(12"). The proposed device have sharps injury protection features. It aids in the prevention of accidental needle stick through the use of an active safety feature. The proposed device is a sterile, single use device. It is sterilized by Ethylene Oxide Gas (EtO) 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 three years. No DEHP, BPA and Natural Rubber Latex are added in the proposed device.
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    K Number
    K210217
    Device Name
    Needleless Connector
    Date Cleared
    2021-05-17

    (110 days)

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

    Jiangsu Caina Medical Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direction, intermittent infusion, continuous infusion or aspiration.
    Device Description
    The proposed device, Needleless Connector, is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy. It can be used for direct injection, intermittent infusion, continuous infusion or aspiration. The proposed device is a needleless connector which can be activated by a male luer, and the flush volume for the device is 5ml. The device can be used for less than 7 days and 100 activations. The Needleless Connector also suitable for power injection of contrast media into the central venous system only through IV line that is also indicated for power injection at a maximum pressure of 325psi and a flow rate of 10ml/s.
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    K Number
    K193022
    Device Name
    Retractable Safety Insulin Syringe
    Date Cleared
    2020-07-20

    (264 days)

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

    Jiangsu Caina Medical Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Retractable Safety Insulin Syringe is a sterile, single use, disposable and non-reusable, automatically 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
    The Retractable Safety Insulin Syringe has the same technological characteristics as the Retractable Safety Syringe(manufacture by Jiangsu Caina Medical Co., Ltd.) as cleared in K191490 at date 2019/10/03. The difference between the Retractable Safety Insulin Syringe and the 1ml Retractable Safety Syringe is only the scale. The Retractable Safety Insulin Syringe works like a conventional insulin syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe plunge, the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container. The Retractable Safety Insulin Syringe is available in various specifications. The proposed device consists of eleven components: (1) plunger. (2) piston. (3) barrel. (4) needle cap. (5) sealing plug. (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub. The proposed device is provided sterile. The product 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 five years.
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