ICU Medical, Inc

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Web: http://www.icumed.com
E-Mail:
Address: 951 Calle Amanecer, San Clemente, California 92673, USA
Phone: +1-(949)-366-2183, 800-824-7890 | Fax: +1-(949)-366-8368 | Map/Directions >>
 
 

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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• Adult-Pediatric Volumetric Infusion Pumps
• Ambulatory Infusion Pumps
• Anesthesia Infusion Pump Tubing
• Anesthetic 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.
• 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.
• Anti-Regurgitation Valve with Blood Tubing Set (FDA Code: FJK / 876.5820)
A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.
• Arterial Blood Sampling Kit (FDA Code: CBT / 868.1100)
An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin.
• Autotransfusion Apparatus (FDA Code: CAC / 868.5830)
An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.
• AV Shunt Cannula (FDA Code: FIQ / 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.
• Batteries & Battery Assemblies for Infusion Pumps
• Bed Transfer Aids
• Blood Bank Supplies (FDA Code: KSS / 864.9050)
Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.
• Blood Pressure Cuff Barriers
• Blood Pressure Cuff With Inflation Systems
• Blood pressure Cuffs (FDA Code: DXQ / 870.1120)
A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.
• Blood Pressure Cuffs and Neoprene Bladders (1-Tube)
• Blood Pressure Cuffs and Neoprene Bladders (2-Tube)
• Blood Pressure Cuffs With Bayonet Connectors
• Blood Pressure Cuffs With Locking-Type Connectors
• Blood Pressure Cuffs With Luer Lock Connectors
• Blood Pressure Cuffs With Screw-Type Connectors
• Blood Transfusion Microfilter (FDA Code: CAK / 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.
• 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.
• Catheter Accessories (FDA Code: KGZ / 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.
• 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
• Closed Male Connector
• Constant-flow Infusion Pump
• 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.
• Continuous Intracranial Pressure Monitor (FDA Code: GWM / 882.1620)
An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.
• Continuous Vacuum Regulators
• Diabetes Infusion Set
• 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.
• Digital Vacuum Regulator
• Disposable Covers for Blood Pressure Cuffs
• Dry and Liquid Heparin Arterial Blood Sampling Kits
• Dual-Channel Volumetric Infusion Pump
• Endoscope Accessories (FDA Code: KOG / 876.1500)
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
• Enteral Irrigation Kit w/Piston Syringe
• 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.
• Fiberoptic Oximeter Catheter (FDA Code: DQE / 870.1230)
A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.
• Flow Directed Catheter (FDA Code: DYG / 870.1240)
A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.
• Fluid Delivery Tubing (FDA Code: FPK / 880.5440)
• Foley Catheter Introducer
• Gastro-Urology Catheter & Accessories (FDA Code: KNY / 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).
• Gastrointestinal Tube and Accessories (FDA Code: KNT / 876.5980)
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
• General Sutures/Needles
• High Three-Mode Continuous Vacuum Regulators
• I.V. Fluid Transfer Unit (FDA Code: LHI / 880.5440)

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