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The RyMed Technologies InVision-Plus CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use. The RyMed Technologies InVision-Plus" CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path. The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumamnii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 ml/sec.

RyMed's InVision-Plus® CS™ with Neutral Advantage™ Technology features pronounced intraluminal catheter fluid pathway protection using a combination of ten mechanical design features incorporated specifically for patient protection. The Neutral Advantage™ Technology features include a smooth swabbable septum surface, septum seal integrity with no gaps or openings, a double microbial barrier, straightthrough fluid pathway, zero dead space, zero fluid displacement, low priming volume, 100% effective blood clearing, saline-only flush option and no clamping sequence or positive pressure syringe technique required. The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems are intended for single patient use in intravenous and blood administration sets without needles, thus eliminating the potential for needle-stick injuries during use. The RyMed Technologies InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port contains silver ions and chlorhexidine, which are intended to inhibit the growth of microorganisms on the treated surfaces of the device, which include the septum and the fluid path. The RyMed Technologies InVision-Plus® CSTM with Neutral Advantage™ Technology Injection Port has been shown to be effective for 7 days against the following microorganisms: Acinetobacter baumannii, Methicillinresistant Staphylococcus aureus, Staphylococcus aureus, Escherichia coli, Candida albicans, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Staphylococcus epidermidis. The subject device is not intended to treat existing infections. The device is not intended to have any effect on contaminated infusion solutions. Correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The InVision-Plus® CS™ with Neutral Advantage™ Technology Injection Port Systems may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. The device is offered in the following configurations: - o Stand alone connector - 0 Administration Sets - o Stopcocks The subject device is composed of materials that have been successfully and safely used in medical devices including the predicate devices. The materials used in the subject device have been subjected to and passed biocompatibility testing. The subject device may be used with low pressure power injectors having a maximum pressure of 325 psi and a maximum flow rate of 10 mL/sec. When used with a low pressure power injector, the subject device must be secured with other devices rated for pressures up to 325 psi with a luer lock connection. The subject devices are sterile single-use devices.

The SprayGenix™ Cryo Ablation System is intended to be used as a cryosurgical tool for destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications.

The SprayGenix™ Cryo Ablation System is a cryosurgical device. consisting of an electronic console, cryo-catheter, nasal/oral gastric tube and cryogen delivery system. The SprayGenix™ Cryo Ablation System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a cryo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The CryMed Cryo-Ablator System is intended to be used as a cryosurgical tool for use in dermatology, gynecology and general surgery.

The Cryo-Ablator System is a cryosurgical device, consisting of an electronic console, cryo-catheter and cryogen tank, The Cryo-Ablator System is used to destroy unwanted tissue by application of extreme cold to a selected site. Liquid Nitrogen is stored in a tank and then propelled through a crvo-catheter to perform the cryo-ablation procedure. The catheter is placed in the appropriate position through the use of visual observation. The cryo-catheter applies the cryogen to a selected area and freezes the unwanted tissue. Cryosurgical procedures are used when surgical resection is not indicated, and may also provide an alternative to typical resection in certain cases.

The RyMed Technologies InVision-Plus™ Injection Port Systems are intended for single patient use in intravenous and blood administration sets without need for needles, thus eliminating the potential for needle-stick injuries during use.

The RyMed Technologies INVISION-PLUS™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y - Injection Port that contain a specialized two part valve made from medical grade Silicone material. The female luer housing, guide washer, and heparin lock are made from medical grade plastics. The valve provides excellent fluid Flow Rates, low Priming Volumes, and reseals after extended use.

The RyMed Technologies SLAV™ Injection Port Systems are intended for single patient use in intravenous and blood administration.

The RyMed Technologies SLAV™ Injection Port Systems are composed of either a Heparin Lock Injection Port, or a Y-Injection Site Port that contain a specialized two piece valve made from a medical grade clear plastic and a medical grade Slicone material. This specialized valve completely eliminates the use of Needles forcing compliance with the new OSHA standards of safety avoiding accidental needle stick injuries, the valve also provides excellent fluid Flow Rates, requires very low Priming Volumes, and it eliminates "dead spaces" that could entrap blood. This valve has the ability to activate injection ports a minimum of 100 times without leaking or change in its performance.