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The Intera Non-coring (Huber) Needles and Special Bolus Needles) and OR Prep Kit are indicated for use with the Intera implanted infusion pumps to administer infusate solutions. Specifically, - the Refill Needles are indicated for emptying and refilling the reservoir of an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump; - the Special Bolus Needles are indicated for delivering bolus injections through an Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump; - the OR Prep Kit is used to prepare the Intera 3000 Hepatic Artery Infusion Pump or CODMAN® 3000 Series Pump prior to implantation.

The Intera Refill Needle is a straight 22 gauge stainless steel non-coring needle with hub and needle cap. The Refill Needle is available in 1", 1 ½", and 2" lengths and is used to empty and fill the reservoir of a subcutaneously implanted infusion pump through the pump septum. The Refill Needle is provided sterile and is intended for single patient use. The Intera Special Bolus Needle is a straight 20 gauge stainless steel non-coring needle with hub and needle cap. A tubing extension set is integrated with the needle hub. The Special Bolus Needle is available in 1 3/8" and 2" lengths and is used to deliver infusate through the pump septum to the pump catheter. The Special Bolus Needle is provided sterile and is intended for single patient use. The Intera OR Prep Kit contains the accessories used to prep and fill the pump prior to implantation and is assembled as a convenience to the end-user with the following sterile, single-use items: - One (1) 22g non-coring (Huber) Refill Needle - One (1) 20g non-coring (Huber) Special Bolus Huber Needle with attached tubing, clamp, and female luer - One (1) 33cm (13") tubing set with clamp and female luer assembled to an empty syringe barrel The empty syringe barrel acts as a liquid waste receptacle to hold the fluid that is passively drained from the infusion pump during pump preparation prior to implantation. The empty syringe barrel and drained fluid are discarded after use and have no direct patient contact. The empty syringe barrel does not include a piston and does not function as a piston syringe.