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The Millennium CRT™ Infusion Pump and Millennium CRT™ Infusion Pump Administration Sets create an infusion system intended for parenteral and enteral administration. This includes, but is not limited to standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, nitroglycerin, Total Parenteral Nutrition (TPN), lipids, enteral fluids, I.V. drugs such as paclitaxel and other chemotherapeutic agents, and epidural administration of anesthetic and analgesic drugs. The pump is capable of drawing fluid from containers or syringes and administering the fluid to a patient through the administration set. The Millennium CRT™ Infusion Pump Administration Sets can also be used as stand-alone devices without the Millennium CRT™ Infusion Pump. When used without the Millennium CRT™ Infusion Pump, the Millennium CRT™ Infusion Pump Administration Sets are also intended for parenteral and enteral administration. However, administration of these fluids is accomplished through gravity infusion. When used for gravity infusion, these sets may be used for administration of standard I.V. fluids (large volume parenterals and small volume parenterals), blood, blood components, lipids, nitroglycerin, TPN, I.V. drugs including paciltaxel and other chemotherapeutic agents, and enteral fluids. The Millennium CRT™ pump and associated administration sets are intended for, but are not limited to use in the hospital, home care and/or nursing home (extended care) settings. The Millennium CRT™ Infusion Pump is intended for use by trained healthcare providers in accordance with the instructions provided in the Operation Manual. All data entry and validation of the Millennium CRT™ Infusion Pump is performed by the trained healthcare provider per a physician's order.

The subject devices include an electrical, external, linear peristaltic, volumetric infusion pump called the Millennium CRT™ Infusion Pump and administration sets called the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRT™ Infusion Pump can only be used with the Millennium CRT™ Infusion Pump Administration Sets. The Millennium CRTM Infusion Pump Administration Sets do not contain a dedicated cassette. However, these sets do contain a free-flow clip that is a special slide clamp that interfaces with the pump. The Millennium CRTTM pump will not function as intended without the Millennium CRT™ sets. The Millennium CRT™ sets can be used either with the pump for pump infusion or without the pump for gravity infusion. The system created by using the Millennium CRT™ Infusion Pump Administration Set with the Millennium CRT™ Infusion Pump is intended to provide accurate and continuous flow of parenteral and enteral fluids to the patient. The pump is software controlled and operates using linear peristaltic crushing action against a straight piece of plastic tubing threaded through the pump mechanism. The system detects occlusions in the patient line downstream. The Millennium CRT™ Infusion Pump Administration Sets are sterile single use devices. The sets are composed of a straight piece of standard tubing, a free-flow clip and various combinations of other standard I.V. set components including filters, check valves, spikes, drip chambers, injection sites (standard needle injection sites and needle free injection sites such as the SafeLine® pre-slit septum injection site and the Clave® Connector luer activated injection site), clamps, measured volume burets, caps or protectors, and luer connectors. All of these standard set components are used in McGaw's currently marketed 510(k) cleared standard gravity and pump I.V. administration sets. The administration set components are welded or bonded and assembled using current McGaw manufacturing procedures to form the completed sets. The Millennium CRT™ Infusion Pump Enteral Administration Set is a non-sterile single use device. This enteral administration set is composed of standard administration set components including a straight piece of standard tubing, a free-flow clip, luers, and a drip chamber. The enteral set also includes a pre-attached enteral fluid bag. The infusion pump contains the following hardware subassemblies: linear peristaltic mechanism assembly, power supply assembly, pole clamp assembly, air-in-line detector assembly, free-flow receptacle assembly, display assembly, and electronics assembly. The linear peristaltic mechanism assembly contains additional subassemblies for downstream occlusion detection. The power supply assembly includes two identical NiMH (Nickel Metal Hydride) batteries. One battery is permanently mounted inside the pump: whereas, the other battery is optional and can be inserted or removed by the user as required to provide additional battery capacity.

The SafeLine I.V. Bag Access Device is intended for multiple withdrawals of fluid from the set port of standard I.V. bags. The spike portion of the SafeLine I.V. Bag Access Device is inserted into the I.V. bag set port and the fluid is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine I.V. Bag Access Device. The fluid in the syringe can then be used for performing "I.V. pushes," to flush patient I.V. lines, or other pharmaceutical uses. The SafeLine I.V. Bag Access Device replaces the use of a traditional metal hypodermic needle to provide needlefree access to I.V. Bags. Thus, eliminating the potential for accidental needlestick injury.

The SafeLine™ I.V. Bag Access Device is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard I.V. bag spike and a spike protector. The SafeLine I.V. Bag Access Device is designed to withdraw drugs from standard size I.V. bags through a blunt plastic cannula attached to a syringe. Thus providing needlefree access of IV bags. As with all of the currently marketed SafeLine devices, the new SafeLine I.V. Bag Access Device is tinted green to signify a needle free SafeLine product.

The SafeLine Multidose Vial Adapter is intended for multiple withdrawals of drug solution from standard size drug vial solid stoppers. The spike portion of the SafeLine Multidose Vial Adapter is inserted into the drug vial solid stopper and the drug solution is withdrawn using a blunt plastic cannula connected to a syringe. The fluid is withdrawn into the syringe through the blunt plastic cannula inserted into the injection site portion of the SafeLine Multidose Vial Adapter. The drug solution in the syringe can then be transferred to an I.V. administration set with a pre-slit septum injection site for administration of the drug solution to the patient. The SafeLine Multidose Vial Adapter replaces use of a traditional metal hypodermic needle to provide needlefree access to drug vials. Thus, eliminating the potential for accidental needlestick injury.

The SafeLine™ Multidose Vial Adapter is an additional accessory device for use with McGaw's SafeLine System. It is a single sterile plastic device composed of a pre-slit rubber septum injection site, a standard drug vial spike and a plastic spike tip protector. The SafeLine Multidose Vial Adapter is designed to withdraw drug solution from the solid stopper of standard size drug vials using a blunt plastic cannula attached to a syringe. Thus providing needlefree access of drug vials. As with all of the currently marketed SafeLine devices, the new SafeLine Multidose Vial Adapter is tinted green to signify a needle free SafeLine product.