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The MaxPlus is a sterile single patient use Positive Displacement Connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxPlus connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

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The MaxPlus Tru-Swab Positive Displacement Connector is an accessory to an Intravascular Administration Set used as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.

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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria, device performance studies, or clinical trial details.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is absent from the provided document.

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