Search Results

Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).

The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).

The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to patient through a cannula placed in the vein or artery.

The Needle Free Connector is a disposable, sterile and non-pyrogenic device intended for use as an accessory of an intravascular infusion device to connect a cannula placed in a vein or artery to infuse patients, including adults and pediatrics. The Needle Free Connector can be divided into two versions according to whether it has a protective cap or not. The Needle free connector with protective cap is composed of Body, Core, Polyester Shell or ABS Shell, and Protective Cap. The Needle free connector without protective cap is composed of Body, Core, Polyester Shell, or ABS Shell, or PC shell. The body is made from polycarbonate, the core made from silicone, the protective cap made from ABS. The PC shell of the device is clear with visible liquid pathway. The device is sterilized by EO gas and the sterilization process is validated. It is a luer activated device that eliminates the risk of needle-stick injuries and can be used for a maximum of 7 days following initial connection and 600 activations. It may be used with power injection procedure to a maximum pressure of 350psi.

KardiFlexTM NC Coronary Dilatation Catheter is indicated for: • balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. - · balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction. - · in-stent restenosis. - · post-delivery expansion of balloon expandable coronary stents.

The KardiFlex™ NC Coronary Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 5.0mm and lengths from 6mm to 30mm. The balloon material is made of a minimally Nylon material and balloons have a rated burst pressure of 22 atmospheres. The minimally material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The KardiFlex™ NC Coronary Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-5.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube). The KardiFlex™ NC Coronary Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

KardiFlex™ PTCA Balloon Dilatation Catheter is indicated for: -balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion. -balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.

The KardiFlex™ PTCA Balloon Dilatation Catheter is designed to allow rapid exchange of the catheter using a standard length of 0.014" guide wire. Balloon diameters range from 1.5mm to 4.0mm and lengths from 6mm to 30mm. The balloon material is made of compliant material and balloons have a rated burst pressure of 16 atmospheres. The compliant material allows high pressure dilatation while maintaining precise control of the balloon diameter and length. The KardiFlex™ PTCA Balloon Dilatation Catheter is a sterile, single use and non-pyrogenic device. The balloon has one (for Ø1.5mm) or two (for Ø2.0-4.0mm) radiopaque platinum marker(s) to aid in positioning the balloon in the stenosis and is designed to provide an expandable segment of known diameter and length of a specific pressure. The dilatation catheter is coated with hydrophilic coating, which is activated when wet. The proximal shaft of the catheter is composed of a female luer connector (hub) bonded to a PTFE coated stainless steel tube (hypotube). The KardiFlex "10 PTCA Balloon Dilatation Catheter consists of 10 parts: hub, strain relief, hypotube, distal outer body, inner body, balloon, radiopaque platinum marker band, tip, balloon sheath and stylet.

Enteral feeding catheter is intended for use in those patients who require intermittent or continuous tube feedings via the nasogastric or nasoenteric route. The target population is adults and pediatrics.

The Enteral Feeding Catheter is composed of a feeding catheter and stylet and can be divided into Funnel type and Enfit type as per the structure of the feeding catheter. For Funnel type, the feeding catheter is composed of tip, body, Y connector. The Y connector has integrated protective cap and strap. For Enfit type, the feeding catheter is composed of tip, body, Y connector, protective cap, and strap. The feeding catheter is made of polyurethane tube with BNF-II-79 hydrophilic coating. The feeding catheter is available in sizes of 6Fr, 8Fr, 10Fr and lengths of 70cm, 100cm, 120cm and 140cm. The length is measured from the distal tip to the proximal hub. The distal end of the feeding catheter features a sideport and is a smooth rounded finish. The proximal end of the feeding catheter features a funnel Y connector that is made of polyurethane or Enfit Y connector that is made of polycarbonate. A stainless-steel stylet with a length corresponding to the feeding catheter is fit inside the feeding catheter. The subject device, Enteral Feeding Catheter, may be introduced directly when there is adequate peristalsis and no gastric outlet obstruction. Alternatively, the feeding catheter may be passed over a stylet. The feeding catheter is intended to be indwelling up to four weeks and is for single-use only.