Profile: Navilyst Medical, Inc. offers medical devices for vascular access, and for the diagnosis & treatment of vascular disease. Our products are used by various healthcare providers including interventional radiologists, interventional cardiologists, oncologists, surgeons, IV nurses & oncology nurses. We offer peripherally inserted central catheters (PICC), ports, chronic dialysis catheters, vascular access accessories and fluid management products. The Xcela® power injectable PICC is designed to deliver the flow rates required for successful contrast-enhanced CTs. Its advanced features such as large lumen diameters, reverse tapered catheter body and radiopacity are designed to augment catheter performance, from catheter placement to care & maintenance. With its broad range of sizes and kit configurations, this PICC provides options in a variety of placement settings, insertion techniques & patient clinical requirements. It is also designed to deliver the power injection flow rates required for contrast-enhanced CTs. The Vaxcel® PICC is a non-valved catheter intended for short- or long-term infusion therapy. It is available in a variety of configurations to satisfy the needs of the inserter. This is designed for image-guided placement. Enhanced radiopacity is designed for improved visualization when using fluoroscopic guidance for insertion and for tip confirmation via chest x-ray. It incorporates a reverse taper extrusion, which is designed for improved kink resistance. The reverse taper is intended to provide greater pushability for easier placement. The catheter body's large lumen diameters are designed to provide greater flow rates at lower pressures and minimize the risk of catheter occlusion. NAMIC® Compensator™ and perceptor manifolds is a single-piece manifold with integral transducer that provides simplified set-up, reduced prep time & crisper, clearer waveforms. The patented design automatically compensates for hydrostatic pressure changes.

The company was founded in 2008, has ~800 employees.

FDA Registration Number: 1317056

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• Safety Scalpel System

• Short-Term Less Than 30 Days Therapeutic Intravascular Catheter (FDA Code: FOZ / 880.5200) An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

• Single Lumen Hypodermic Needle (FDA Code: FMI / 880.5570) A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.

• Temporary Pacemaker Electrode (FDA Code: LDF / 870.3680) A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

• Therapeutic Intravascular Catheter (FDA Code: LJS / 880.5970) A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

• Tripolar Electrode Cables

• Ultrasound System

• Ultrasound Transducer Accessories

• Ultrasound Transducer Spare Parts

• Ultrasound Transducers

• Urological Catheter Care Kits

• Urological Catheters (FDA Code: KOD / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Urological Catheters, Intermittent Catheters

• Vascular Access Transducer Cover