Search Results

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to addition of new needle lengths and specifications.

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B, Type D and Type E), needle infusion tubing (pressure resistance or non-pressure resistance), Yinjection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days. This submission is new design primarily involve changes to the type C name, the addition of new needle lengths and new type E.

PowerLoc™ Max Power Injectable Infusion Set: The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles. SafeStep™ Huber Needle Set: The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only. The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site. SafeStep™ Huber Needle Set: The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. These devices may be used in any patient population with an implanted vascular port. Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.

The needle is used to access surgically implanted vascular ports. Safety Huber Needles is a standard non coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. This device is for adult use only. In addition, when used with ports that are indicated for power injection of contrast media into the central venous system, the high pressure resistant model is indicated for high-pressure injection of contrast media for CT imaging.

Safety Huber Needle is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by sheathing the needle. The device includes an integrated extension set consisting of a Huber needle and safety mechanism (Type B and Type C), needle infusion tubing (pressure resistance or non-pressure resistance), Y-injection site, clamp and female Luer lock adapter. The pressure resistance tubing can be used for power injection up to 330 psi. The device will be retained on patient for 24h to 7 days.

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.

Huber Needle Infusion Set: The 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 19G-22G needles of device are 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. Safety Huber Needle Infusion Set: 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 in the prevention of accidental needle sticks. The 19G-22G needles of device are 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.

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s). The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

The ISP Safety Huber Needle Infusion Set is a safety IV administration set with a non-coring, ninety degree, right angled Huber needle, used to access a patient's surgically implanted vascular port. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or to withdraw blood through the implanted vascular port. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needle within the wing to help prevent needlestick injuries when using the device for vascular port access.

The Infusion Safety Products, Inc. ISP Safety Huber Needle Infusion Set is a non-coring safety IV administration set used to access a patient's surgically implanted vascular port. The Safety Huber Needle Infusion Set is constructed with a 90°, non-coring Huber needle that is available in 19ga, 20ga and 22ga and in ½", ¾", 1″ and 1½" lengths. It is offered in various model numbers. The device is lipid resistant and contains non-latex containing products. The PVC Tubing is non-DEHP, with a flow rate of approximately 5cc per sec. max / CT rated to 300 psi. The Safety Huber Needle Infusion Set is packaged in a semi-rigid form fill and seal package with a 1059B Tyvek® lid. The sets are sterilized using a validated ethylene oxide method. The ISP Safety Huber Needle Infusion Set is intended to administer fluids or withdraw blood through the implanted vascular port (not included with the ISP Safety Huber Needle Infusion Set device is offered in the following configurations, each with various needle gauges and needle lengths: 1. Huber needle in a needle holder in a safety wing, a 7.50" length of PVC Tubing, ratchet clamp, female luer lock and vented-protector cap. Approximate Priming Volume: 0.25cc. 2. Huber needle in a needle holder in a safety wing, a 4.12″ length of PVC tubing with a ratchet clamp attached to a Y port with a non-vented cap, a second 4.12″ length of PVC off the Y port with a ratchet clamp, a female luer lock and non-vented protector cap. Approximate Priming Volume: 0.35cc. The ISP Safety Huber Needle Infusion Set facilitates safe removal of the needles by encapsulating the needle within the wing to help prevent needle stick injuries when using the device for vascular port access. The safety mechanism is engaged when the needle is removed from the access port. As the set is removed from the patient, the wing encapsulates the needle, making an audible click when secure, to prevent needle sticks to the clinician.

The Surecan Safety II power-injectable safety non-coring needle is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Surecan Safety II safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needle-sticks. When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media. For power injection of contrast media, the maximum flow rates at 325 psi are 5mL/s for 19 gauge and 20 gauge needles and 2mL/s for the 22 gauge needles.

The Surecan Safety II power-injectable safety non-coring needle is a single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. This device contains a non-coring angled needle and a manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle tip during removal. The intended patient population is for patients with implanted intravenous access ports. The Surecan Safety II needles are available in different sizes from 19 gauge to 22 gauge and have an overall needle length ranging from 0.5-1.5 inches (12mm-38mm). The Surecan Safety II needles will be available in two configurations: -with a Y-site and a preconnected Caresite luer access device -without Y-site or Caresite luer access device When used with ports that are indicated for power injection of contrast media into the central venous system, the Surecan Safety II needle is also indicated for power injection of contrast media. The Surecan Safety II is designed with flexible wings which allow the user to securely hold the device for insertion and removal of the needle. The base and bottom plate are made of clear plastic that allow the user to visualize placement of the needle. A foam pad is present on the patient-contacting side of the safety mechanism. The overall assembly has a low profile to assist with the placement of a securement dressing following insertion of the needle into the port.

The PowerLoc® MAX Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention which reduces the risk of accidental needlestick injuries by shielding the needle is used to access surgically implanted vascular ports. The PowerLoc® MAX Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles. The SafeStep® Huber Needle Set is a device intended for insertion of a subcutaneously implanted port and for the infusion of fluids into the port. The Safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.

PowerLoc® MAX Power-Injectable Infusion Set The PowerLoc® MAX Power-Injectable Infusion Set is a standard non-coring intravascular infusion set with a non-coring Huber type right angle needle and a manually activated needle-stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is used to access surgically implanted vascular ports and is indicated for use in the administration of fluids and drugs, as well as blood sampling. The PowerLoc® MAX Power-Injectable Infusion Set is also indicated for power injection of contrast media into the central venous system only through an implanted port that is also indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles and 2 ml/s for 22 gauge needles. The PowerLoc® MAX Power-Injectable Infusion Set is offered with and without a Y-site. SafeStep® Huber Needle Set The SafeStep® Huber Needle Set is a standard right angle Huber needle and infusion set with a needlestick prevention feature, designed for use with a vascular access infusion system. The device also includes an integrated extension set consisting of infusion tubing, a non-vented male Luer cap, female Luer lock adapter, pinch clamps, and safety guard handle and base. It is manufactured with conventional medical grade, biocompatible materials. The SafeStep® Huber Needle Set operates as a standard Huber needle with the addition of a safety feature to aid in the prevention of needlestick injuries to the health practitioner. The SafeStep® Huber Needle Set is offered with and without a Y-site. Stabilization accessory The stabilization accessory is intended for use as an accessory to the subject PowerLoc® MAX Power-Injectable Infusion Set and SafeStep® Huber Needle Set, and is supplied pre-loaded with the subject devices. It is placed centrally over the implanted port so that the base surrounds the implanted port under the skin. The infusion set needle handle is pressed down until the needle has entered the port septum, then the stabilization accessory is lifted off of the needle. The stabilization accessory is then discarded per hospital protocol.