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The MaxGuard Advanced Luer Activated Device with Antimicrobial Technology is a sterile single use positive displacement connector for needleless access to the IV line and/or IV catheter during IV therapy. The MaxGuard Connector can be used for direct injection, intermittent infusion, continuous infusion or aspiration. The MaxGuard with Antimicrobial Technology may inhibit the growth of microorganisms on the surfaces of the MaxGuard device. The antimicrobial agent is intended to reduce the possibility that the device may become microbially contaminated. The antimicrobial agent is not intended to be used as a treatment for existing infections. The MaxGuard with Antimicrobial Technology has been shown to provide a 4+ log reduction of the following organisms: Staphylococcus aureus, ATCC 6558 Staphylococcus epidermidis. ATCC 12228 Escherichia coli, ATCC 8739 Enterococcus faecalis, ATCC 51299 Pseudomonas aeruginosa, ATCC 9027 Klebsiella pneumonia. ATCC 4352 Candida albicans, ATCC 10231

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The Tru-Swab™ Stopcock 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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The Drug Access Spike is a device used to aspirate solutions/medications from a drug container (drug vial/bag). The Drug Access Spike may incorporate componentry that aid in the prevention of accidental needle sticks.

The Drug Access Spike is a plastic conduit that is a means to access drug containers. The device is center on top of the stopper of a drug container. The Drug Access Spike is pushed through the rubber stopper and locks into position. A syringe is attached to the Drug Access Spike in order to draw from the drug container. After detaching the syringe, solution/medications are dispensed into a needleless injection site. The use of a Drug Access Spike eliminates the need for a conventional needle. On multi-dose containers, a needleless injection site is bonded to the Drug Access Spike. This allows the drug container to be accessed multiple times while maintaining a physical barrier to prevent microbial ingress. The needleless injection port incorporated into some of the configurations of the Drug Access Spike is the NAC " Needleless Access Connector. The NAC " Needleless Access Connector was previously cleared under SE-K011193 and SE-K992268.

The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.

The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications. Components will be assembled into standard configurations specified by the customer and packaged.

The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed 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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