IMPORTANT RISK INFORMATION Dilator Indications for Use: The Jet Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery. Contraindications: Known or suspected allergies to the device. Peelable Introducers Contraindications: Known or suspected allergies to the device. The Peelable Introducer is not designed for use in the arterial system or as a hemostatic device. Introducer Needle Indications for Use: The Jet Introducer Needle is used for the percutaneous introduction of guidewires. Contraindications: Known or suspected allergies to the device. Guidewires Indications for Use: The Jet Guidewires are for general intravascular use, including the peripheral vasculature, to facilitate the selective placement of medical devices in the vessel anatomy. This device is not intended for coronary or cerebrovascular use. Contraindications: Known or suspected allergies to the device. 2F & 3F Access Set Indications for Use: The Jet 2F and 3F Access Set is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children. Contraindications: This catheter is not intended for any use other than that which is indicated. Do not implant catheter in thrombosed vessels. The presence of skin related problems around the insertion site (infection, phlebitis, scars, etc.). The presence of device related bacteremia or septicemia. Previous history of venous/ subclavian thrombosis or vascular surgical procedures at insertion site. Fever of unknown origin. The patient’s body size is insufficient to accommodate the size of the implanted device. The patient is known or is suspected to be allergic to materials contained in the device. Past irradiation of prospective insertion site. Local tissue factors will prevent proper device stabilization and/or access.
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