Profile: Merit Medical Systems, Inc. manufactures medical devices used in diagnostic and interventional cardiology & radiology procedures. Our primary products are inflation devices, diagnostic and therapeutic catheters, guide wires, pressure monitoring disposables, fluid delivery systems, medication syringes, safety products and needles. Our diagnostic cardiology catheters are available in Softouch and Performa styles. They are designed with a nylon shaft and wire braid. Softouch catheters are our original workhorse catheters. We offer a broad selection of fluid management products ranging from simple fluid spikes and drip chambers to complex trifurcated tubing sets. We provide an assortment of safety products for fluid and contrast management that may help decrease potential injuries to both patients & health care workers.

The company was founded in 1987, has revenues of USD 100-500 Million, has ~1700 employees and is ISO 9001, CE certified. NASDAQ:MMSI (SEC Filings)

FDA Registration Number: 1721504

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• Adult Vessel Sizing Catheters

• Angiographic Injector

• Angiographic Injector and Syringe (FDA Code: DXT / 870.1650) An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.

• Angiographic Needle

• Angiography Needles

• Angiography Procedure Kits

• Angioplasty Accessories

• Balloon Inflation Syringe (FDA Code: MAV / 870.1650)

• Balloon Type Catheter (FDA Code: GBA / 878.4200) An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Bile Collection Bag (FDA Code: EXF / 876.5010) A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

• Cardiology Catheters

• Cardiology Surgery Instruments

• Cardiopulmonary Bypass Adaptor (FDA Code: DTL / 870.4290) A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.

• Cardiopulmonary Bypass Heat Exchanger (FDA Code: DTR / 870.4240) A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.

• Cardiovascular Trocar (FDA Code: DRC / 870.1390) A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.

• Catheter Accessories (FDA Code: KGZ / 878.4200)

• Catheter Introducers (FDA Code: DYB / 870.1340) A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

• Catheter Introducers, MULLINS

• Catheter Introducers, Mullins Design

• Catheter Needle (FDA Code: GCB / 878.4200)

• Continuous Flush Catheter (FDA Code: KRA / 870.1210) A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

• Contrast Management Systems

• Diagnostic Biliary Catheter (FDA Code: FGE / 876.5010)

• Diagnostic Guide Wires

• Diagnostic Guidewires

• Diagnostic Intravascular Catheter (FDA Code: DQO / 870.1200) An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Drainage Catheters and Accessories

• Embolectomy Catheters (FDA Code: DXE / 870.5150) An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

• Emesis Basin (FDA Code: FNY / 880.6730) A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.

• Endoscopic Electrosurgical Unit and Accessories (FDA Code: KNS / 876.4300) An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

• Enteral Irrigation Kit w/Piston Syringe

• Esophageal Prosthesis (FDA Code: ESW / 878.3610) An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

• Expandable Tracheal Prosthesis (FDA Code: JCT / 878.3720) The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

• Extravascular Blood Pressure Transducer (FDA Code: DRS / 870.2850) An extravascular blood pressure transducer is a device used to measure blood pressure by changes in the mechanical or electrical properties of the device. The proximal end of the transducer is connected to a pressure monitor that produces an analog or digital electrical signal related to the electrical or mechanical changes produced in the transducer.

• Fluid Delivery Tubing (FDA Code: FPK / 880.5440) An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

• Fluid Dispensing Systems

• Fluid Management Systems

• Foley Catheter Introducer

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• Guide Catheters

• Guide Wire Accessory

• Guidewire Catheter (FDA Code: DQX / 870.1330) A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

• Hemodynamic Pressure Monitoring

• Hemostasis Valves

• Implantable Venous Access Catheter Introducer Kits

• Implanted Hemodialysis Catheter (FDA Code: MSD / 876.5540) A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

• Inflation Devices

• Intravascular Catheter Securement Device (FDA Code: KMK / 880.5210) An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin.