Important Risk Information 2F & 3F ACCESS SET Indications for Use: The Medcomp® 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. ACCESS SET Indications for Use: The Medcomp® Access Set is used for percutaneous introduction and placement of guidewire or catheter for interventional radiology procedures. Contraindications: Known or suspected allergies to the device. DILATOR Indications for Use: The Medcomp® 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. GUIDEWIRE Indications for Use: The Medcomp® 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. INTRODUCER NEEDLE Indications for Use: The Medcomp® Introducer Needle is used for the percutaneous introduction of guidewires. Contraindications: Known or suspected allergies to the device. MICRO-STICK® Indications for Use: The Medcomp® Micro-Stick® Set is indicated for percutaneous introduction of up to a 0.038 inch guidewire or catheter into the vascular system following a small 21 gauge needle stick. The Micro-Stick® Set is not intended for use in the coronary or cerebral vasculature. Contraindications: Known or suspected allergies to the device. PEELABLE INTRODUCER 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. VALVED PEELABLE INTRODUCER Contraindications: Known or suspected allergies to the device. The Valved Peelable Introducer is not designed for use in the arterial system or as a hemostatic device. SECUREMENT Indications for Use: StatLock® Catheter Securement is a stabilization device for Medcomp® Tesio® Hemodialysis Catheter. Contraindications: Known or suspected allergies to the device. TUNNELER Indications for Use: The Medcomp® Tunneler is used to dissect tissue to create the subcutaneous tunnel opening. Contraindications: Known or suspected allergies to the device. SAFETY HUBER NEEDLE INFUSION SETS Indications For Use: The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle sticks. The S-1s-1 type is also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G. Refer to Instructions for Use provided with the product for complete instructions, warnings, precautions, and contraindications. Observe all instructions for use prior to using products. Failure to do so may result in patient complications.
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