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The Nouvo Safety Set IV Catheter are indicated for insertion into a patient's vascular system to sample blood. Infusion of fluids such as solutions, parenteral nutrition of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 18G-22G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

The Nouvo Safety Set is an over the Needle Intravascular Catheter, peripheral, it incorporates the passive safety clip to help prevent needle stick injuries. The catheter is made from a radio-opaque polyurethane (PUR) material. The devices have a septum, stabilization platform, integrated extension tubing, c-clamp, single luer, needle free connector, safety clip, access split septum with site luer and vent plug. The needle cover protects the needle and catheter. The color of the catheter hub identifies the gauge size, the catheter gauge size and length are identified on the product packaging. The Nouvo safety set IV catheter is provided sterile and non-pyrogenic for single use only. The Nouvo safety set IV catheter is not made with natural rubber latex or PVC. The subject device shares the similar technological characteristics, principles of operation and the same fundamental scientific technology as the predicate device. Both devices have needleless adaptors and passive safety features. The Needleless adaptor used in the subject device is FDA cleared. The Nouvo Safety Set has the following features: needle cover, introducer needle, needle hub, radiopaque catheter, colored wings, catheter hub, C-clamp, extension tube with or without the N-Pules needles connection (single port, single port with needle free valve, dual port with needle free valve) cleared under K220288 (NP Medical). The immediate flashback system has a plug that prevents leaking and seepage. Upon removal, the safety clip is engaged to prevent needle sticks. There are no additional accessories included with the Nouvo Safety Set.

The Polysafety BC IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 18G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polysafety BC Adva IV Catheter are indicated for short-term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition, and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 180-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polywin Safety IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi. The Polywin Safety Adva IV Catheter are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood or administer fluids such as solutions, parenteral nutrition and administration of other drugs. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused and duration of therapy. The 14G-24G catheters may be used intravascularly with power injectors at a maximum pressure of 300psi.

The Polysafety-BC safety IV Catheter is an over-the-needle blood control. Peripheral passive Safety IV Catheter incorporates a safety clip to help prevent needle-stick injuries & blood control valve to reduce blood exposure during initial catheter placement, blood sampling, withdrawal of the needle, and connection of the luer. The Polysafety BC Safety IV Catheter is provided with a detachable or integrated, flexible perforated soft wing for providing ventilation & skin maceration. The device also incorporates a 'quick flash back'. The Polywin safety IV Catheter is an over the needle, Peripheral passive Safety IV Catheter that incorporates a safety clip to help prevent needle- stick injuries. The Polywin Safety Adva IV Catheter provided with quick flash back features.

The Polyshield and Polyguard Safety IV Catheters are indicated for short term use (less than 30 days) for insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids. The catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. The 14 - 24G catheters may be used intravascularly with power injectors at a maximum pressure of 300 psi.

The Polyshield and Polyguard Safety IV Catheters are over-the-needle, peripheral safety IV catheters that incorporate an active sharps prevention needle shield. The 'BC' versions also incorporate a blood control feature, and the 'Adva' versions include 'quick flash back' needle technology. The devices are available in multiple gauge sizes and lengths.

For administration of fluid from a container into the patient vascular system through a vascular access device.

The Polyfusion IV Administration Sets are available in multiple configurations. In more detail: Polyfusion NFV IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The set may include a vented or non-vented universal spike, drip chamber, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 µm inline filter, slide clamp, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 15 drops/ml and 60 drops/ml. Different lengths are available, from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process. Polyfusion Air Stop IV Administration Sets: Used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The inclusion of an air stop filter maintains a constant fluid level in fluid delivery tubing and reduces the possibility of air entering the line when the I.V. bottle/bag is empty. The set may include a vented or non-vented universal spike, drip chamber, air stop filter, fluid delivery tubing, flow regulator, stop cock, back check valve, needle free valves, 0.2 um inline filter, slide clamps, Luer connectors, and priming filters. Four different drip rates are available, viz: 10 drops/ml, 20 drops/ml and 60 drops/ml. Different lengths are available from 196 cm to 276 cm, together with options for certain components being made either from PVC which has not been manufactured using DEHP plasticiser or using an alternative material which has not been manufactured with either PVC or DEHP. The sets are labeled for prescription use (Rx only) and are supplied sterile for single use only, with a sterilization assurance level (SAL) of 10-6 achieved by means of a validated ethylene oxide sterilization process.