Profile: ICU Medical, Inc. deals with safety medical systems. Our antimicrobial clave provides at least a 4-log bacterial kill rate for a continuous 96-hour use life. This method of manufacturing eliminates the risk of the antimicrobial additive scraping or wearing away over time and repeated use. Clave is the only connector which has been proven to reduce intraluminal catheter colonization in a randomized clinical trial. The reversed, split-septum technology and dedicated internal fluid path makes the clave least likely to transmit bacteria than any other brand. It has been proven effective with two gram negative and two gram positive bacterial strains. Our dyePod contrast management system provides an effective vehicle to improve the efficiency of the lab and to reduce the expense related to unused contrast. Angiographic catheters require hemostatic flow control devices for safe handling of guide wires and flushing with fluids in order to avoid in-catheter clotting and potential emboli. The new H-Flow valve is a patented luer activated self sealing device which allows for convenient placement and positioning of guide wires and micro catheters through an angiographic catheter with little or no leakage.

The company was founded in 1984, has ~1700 employees and is ISO 9001, ISO 9002, CE certified. NASDAQ:ICUI (SEC Filings)

FDA Registration Number: 1713468

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• Implantable Venous Access Catheter Introducer Kits

• Infant Disposable Blood Pressure Cuffs

• Infusion Pump Analysis System

• Infusion Pump Repair

• Infusion Pump Service Parts

• Infusion Pump Stands

• Infusion Pump Tester

• Infusion Pumps, Ambulatory Pumps

• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices.

• Intravenous Administration Kit (FDA Code: FPA / 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.

• IV Fluids

• IV Medication Delivery Systems, volumetric infusion pumps

• IV Sets

• IV Stand Accessories, Multi-Infusion Pump

• Low Two-Mode Continuous Vacuum Regulators

• MRI Infusion Pump Systems, Infusion System Accessories

• MRI Safe Blood Pressure Cuff

• Multiple Lumen Catheter (FDA Code: GBP / 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.

• Neonatal Disposable Blood Pressure Cuffs

• Neutral Displacement Connector

• Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN / 870.1130) A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

• Non-Invasive Tubing (FDA Code: GAZ / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Oximeters (FDA Code: DQA / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.

• PCA Pumps, Infusion Pump

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725) An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

• Piston Syringe (FDA Code: FMF / 880.5860) A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

• Pressure Connector

• Pressure Infusor for I.V. Bags (FDA Code: KZD / 880.5420) A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

• Product Development, Hand-held Infusion Pump Controller

• Product Development, Infusion Pumps

• Radiofrequency Physiological Transmitter/Receiver System (FDA Code: DRG / 870.2910) A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

• 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.

• Silicone Penrose Drainage Tube

• Silicone T-Y Drainage Tube

• Silicone Y-Drainage Tube

• 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.

• Single-Function Pre-Programmed Diagnostic Computer (FDA Code: DXG / 870.1435) A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

• Standard Three-Mode Continuous Vacuum Regulators

• Standard Two-Mode Continuous Vacuum Regulators

• Sterile Specimen Container (FDA Code: FMH / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Stopcock, I.V.Set (FDA Code: FMG / 880.5440)

• Straight Catheter (FDA Code: EZD / 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).

• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• Surgical Tables Accessories, Infusion Stand

• Surgical/Free-Flow Vacuum Regulator

• Syringe Infusion Pump

• 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.

• Thermal Regulating System (FDA Code: DWJ / 870.5900) A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.

• Thermodilution Probe (FDA Code: KRB / 870.1915) A thermodilution probe is a device that monitors cardiac output by use of thermodilution techniques; this device is commonly attached to a catheter that may have one or more probes.

• Thoracic Vacuum Regulator