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The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal.

The Cook Vascular VITAL-JECT Power Injectable Safety Infusion Set is intended to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick after use, the attached safety guard fully encapsulates the needle when manually activated during withdrawal. When used with a power Injectable vascular implant port, the Cook Vascular Safety Infusion Set is indicated for power injection of contract media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s using contrast with a maximum viscosity of 11.8cP. The device consists of a protector cap, female luer lock, PVC tubing, two each 4 inch tubing length, a pinch clamp, with a needle free y-site, a butterfly wing, a safety needle guard, an AISI 304 (19 ga) stainless steel needle and a needle sheath. The components and the processes use to manufacture these solution administration sets are the same as the currently legally marketed by Command Medical, K033515 HuberPRO™ Safety Huber Infusion Set. Cook Vascular, Inc. will label and sterilize the final product. The proposed device is manufactured exactly the same as the currently marketed device. (K033515)