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A system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

Plastic Port Implantable Venous Access Systems consist of a plastic portal (standard or Low Profile™ size), silicone or polyurethane catheter connector, PORT-A-CATH® access needle, blunt needle, and vein pick. The systems will be made available with and without introducer sets.

A system is indicated when a patient requires prolonged or repeated intra-arterial infusion.

A PORT-A-CATH® II Trans-Arterial Percutaneous System consists of a portal with a self-sealing silicone septum, accessible by percutaneous needle puncture, and single lumen catheter. The following accessories are provided with the portal and catheter: PORT-A-CATH® access needle, blunt needle, extra-thin wall introducer needle, dilator/sheath assembly, guidewire and syringe.

A P.A.S. PORT® system is indicated when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling.

The P.A.S. PORT® Elite System is similar to the current commercially available P.A.S. PORT System. The systems have the identical outlet tube, catheter connector and catheter. The P.A.S. PORT® Elite System differs from the current commercially available P.A.S. PORT System as follows: modified portal shape, increased septum diameter, new portal housing material, and a pierceable rear suture hole. The P.A.S. PORT® Elite System will be made available with a sensor assembly and/or introducer set.

The luer activated needleless injection site is designed for use with various SIMS Deltec, Inc. administration sets or syringes for fluid delivery.

The purpose of this submission is to offer an alternate injection site ("Luer Activated Needleless Injection Site") for use with various Deltec administration sets. The injection site is a valve and is accessed using needleless syringes or IV administration sets.

The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.

The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.

The CADD-Prizm® High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag. The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.

The purpose of this submission is to offer an alternate 1.2 µ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.

The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.

The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.