Search Results

Reprocessed Cordis Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

The reprocessed Cordis Catheters are available in a broad variety of French sizes and configurations. These catheters combine an atraumatic tip with a braided body.

The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.

The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.

The Reprocessed VersaCross Steerable Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum. The Reprocessed SureFlex Steerable Guiding Sheath is introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.

The Reprocessed VersaCross Steerable Sheath consists of three components; a Reprocessed VersaCross Steerable Sheath, a Reprocessed VersaCross Transseptal Dilator, and a 0.035" J-tipped mechanical quidewire. The Reprocessed VersaCross Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The Reprocessed VersaCross Transseptal Dilator provides support for the sheath, features a tapered tip and a shaft that can be reshaped manually. Radiopaque tips maximize visualization of the sheath the dilator during manipulation. The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating. The Reprocessed SureFlex Steerable Guiding Sheath consists of three components: a reprocessed sheath, a reprocessed dilator and a J-tipped Mechanical Guidewire. The Reprocessed SureFlex Steerable Sheath is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The sheath provides superior torque control and is flexible. The radiopaque tip maximizes visualization of the sheath during manipulation. The dilator provides support for the sheath and has a tapered tip. The J-tipped Guidewire, hereafter referred to as the "guidewire", comprises a stainlesssteel core with a flexible, spiral shaped PTFE coated steel coil along the full length of the device. The guidewire is coated in its entirety with a hydrophobic lubricious coating for smoother device manipulation. No pre-conditioning is required for this coating. Note: Only the steerable sheaths and dilator are subject of this submission. The guidewires are purchased off-the shelf and packaged with the reprocessed devices.

The Insignis™ Syringe Infusion System is specifically indicated for the subcutaneous infusion of the following human plasma-derived immunoglobulins when used according to the FDA approved biologic labeling: Cuvitru®, Immune Globulin Infusion (Human) 20% (manufactured by Takeda®); Hizentra®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by CSL Behring®); and Xembify®, Immune Globulin Subcutaneous (Human) 20% Liquid (manufactured by Grifols®) in the home, hospital, or ambulatory settings when administered according to the approved biologic or drug product labeling. The system is intended for use by clinicians and lay users. It is intended for use in adults and in adolescents ages 13-21. For adolescents, it is to be operated under the supervision of an adult after instruction is provided by a healthcare provider. The Insignis TM Syringe Infusion System with the Insignis Syringe Driver and Intravenous Controller, is specifically indicated for the intravenous infusion of fluids such as 0.9% Sodium Chloride (normal saline) and dextrose solutions, and the following antibiotics when used according to the FDA approved drug product labeling: vancomycin, ertapenem, meropenem, oxacillin, and tobramycin.

The Insignis™ Syringe Infusion System is a portable mechanical infusion system that operates without electricity. The Insignis system is intended to deliver indicated fluids subcutaneously or intravenously, depending on the prescribed medicine type, route of administration, and dose. The Insignis system incorporates into its design, a means to maintain a constant nominal pressure (13.5 psi), a controlled flowrate within a restrictive tubing circuit and needles to ensure the desired flowrate of medication to the patient is achieved. The spring-loaded Insignis™ Syringe Driver a constant mechanical force to the plunger of a BD 50 mL syringe (ref. #309653), that dispenses fluid through a restricted flowrate tubing and / or needle set. The Insignis system can infuse the rated BD syringe volume of 0 - 50 mL. Through a selection of IHS products total flowrates of 8 mL/hr -250 mL/hr are available: application specific. - A. For subcutaneous immunoglobulin (SCIg) administrations, the Insignis system includes the OneSett™ Subcutaneous Administration Set, which consists of a selectable rate flow controller connected in-line to an administration set comprised of 1 - 4 needle set configurations (6mm, 9mm, 12 mm, and 14mm lengths). The OneSett is dedicated to deliver 20% concentrate SCIg drugs at specific flowrates which meet the drug manufacturer's package inserts recommended flowrate limitations. The selectable rate flow controller controls the flowrate delivered to each subcutaneous needle site. - B. For intravenous administrations, the Insignis system includes the Intravenous Controller, which consists of a selectable rate flow controller connected in-line to a tubing set. The Intravenous Controller is dedicated to delivering select antibiotics, and saline and dextrose solutions. Again, the selectable rate flow controller allows for selectable and controllable flowrates. For administering the prescribed medications, the Insignis system requires that the user fill the syringe with the prescribed medications, connect the infusion set to the syringe, eliminate air from the fluid line, secure the syringe into the Insignis™ Syringe Driver, connect to the infusion set to the patient, and load the syringe driver to begin the infusion. The system is comprised of the Insignis™ Syringe Driver, a syringe, and either intravenous or subcutaneous infusion sets. To elaborate: - a. The Insignis™ Syringe Driver provides the constant driving force to dispense fluids. - b. The syringe is the reservoir that holds the fluids (manufactured by Becton & Dickinson). - c. The infusion sets (intravenous or subcutaneous) form the fluid path and delivers the fluid to the patient at controlled flowrates.

The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.

Not Found

Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case: CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural. The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The Reprocessed Agilis NxT Introducer is indicated when introducing various cardiovascular catheters into the heart including the left side of the heart through the interatrial septum.

The reprocessed Agilis NxT steerable introducer consists of a steerable sheath, dilator, and quidewire which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization.

The Reprocessed NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood, and infusing solutions.

The reprocessed NRG Transseptal Needle delivers radiofrequency (RF) power in a monopolar mode between its distal electrode and a commercially available Disposable Indifferent (Dispersive) Patch (DIP) Electrode, which is in compliance with IEC 60601-2-2. The NRG Transseptal Needle is loaded through a Transseptal Sheath/Dilator set and is connected at its proximal end to the BMC Radiofrequency Puncture Generator via the BMC Connector Cable and optionally to an external pressure monitoring system via a luer connection. The dimensions for the reprocessed NRG Transseptal Needle can be found on the device label. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures. As well, the active tip is specially shaped to be atraumatic to the cardiac tissue unless RF energy is applied.

The reprocessed cable provides an electrical connection between the IntellaMap Orion Mapping Catheter and the Signal Station of the Rhythmia Mapping System. The reprocessed Umbilical Cable is intended to be used with an Orion Mapping Catheter during electrophysiology procedures, electroanatomical mapping, intracardiac stimulation (pacing) and/or recording of electrical potentials.

The reprocessed umbilical cable is an insulated, multi-conductor cable that us 200 cm (6.6 ft) in length with multi-pin connectors at each end.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheters are designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. This device is not currently indicated for use in cerebral vessels. The Reprocessed Eagle Eye Platinum RX Digitial IVUS Catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter incorporates a cylindrical ultrasound transducer array. The array radiates acoustic energy into the surrounding tissue and detects the subsequent echoes. The information from the echoes is used to generate real-time images of the coronary and peripheral vessels. The Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter utilizes an internal lumen that allows the catheter to track over the 0.014" (0.36 mm) guide wire. The guide wire exits from the guide wire lumen approximately 24 cm proximal to the catheter tip. The catheter is introduced percutaneously or via surgical cut down into the vascular system. Three 1 mm-long radiopaque markers are incorporated on the internal lumen positioned 10 mm apart from distal edge to distal edge. starting 10 mm from the proximal edge of the portion of the scanner marker tube normally visible under fluoroscopy. The Eagle Eye Platinum RX Digital IVUS Catheters are exclusive use with Volcano s5 Series and CORE Series of Systems. This catheter will not operate if connected to any other imaging system. A hydrophilic coating is applied externally to a distal portion of the catheter.