Profile: Smiths Medical Deutschland GmbH provides medical devices for the hospital, emergency, home and specialist environments. Our Point-Lok® device is a needle safety solution for needles found in epidural, spinal and other procedural trays. Our BCI® 3301 pulse oximeter and Digit™ finger pulse oximeter are suitable to the needs of the respiratory care professional. Our CozMore® insulin technology system combines insulin pump therapy, blood glucose monitoring, personalized insulin pump programming and data management.

FDA Registration Number: 9617646
US Agent: Jeffrey Duncan / Smiths Medical Asd, Inc.
Phone: +1-(612)-206-2917  E-Mail:

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• 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.

• Conventional Laryngoscopes

• Cricothyrotomy Kits (FDA Code: OGP / 868.5800) A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

• Diagnostic Capnographs

• 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.

• Differential Ventilation Tracheal/Bronchial Tube (FDA Code: CBI / 868.5740) A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.

• Direct Patient Interface Nebulizer (FDA Code: CAF / 868.5630) A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

• Direct Patient Interface Respiratory Gas Humidifier (FDA Code: BTT / 868.5450) A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

• 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 (FDA Code: KDC / 878.4800)

• Ear Oximeter (FDA Code: DPZ / 870.2710) An ear oximeter is an extravascular device used to transmit light at a known wavelength(s) through blood in the ear. The amount of reflected or scattered light as indicated by this device is used to measure the blood oxygen saturation.

• Electrocardiograph (FDA Code: DPS / 870.2340) An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

• Emergency Airway Needle (FDA Code: BWC / 868.5090) An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.

• End-tidal Carbon Dioxide Monitors

• Endotracheal Tubes

• Endotracheal Tubes, Close Fitting

• Endotracheal Tubes, High Volume Tapered

• Enema Kit (For Cleaning Purpose) (FDA Code: FCE / 876.5210) An enema kit is a device intended to instill water or other fluids into the colon through a nozzle inserted into the rectum to promote evacuation of the contents of the lower colon. The device consists of a container for fluid connected to the nozzle either directly or via tubing. This device does not include the colonic irrigation system (876.5220).

• Epistaxis Balloon (FDA Code: EMX / 874.4100) An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

• Esophageal Stethoscopes (FDA Code: BZW / 868.1910) An esophageal stethoscope is a nonpowered device that is inserted into a patient's esophagus to enable the user to listen to heart and breath sounds.

• ETCO2 Monitors

• Extension Airway Connector (FDA Code: BZA / 868.5810) An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.

• Extravascular Blood Flow Probe (FDA Code: DPT / 870.2120) An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.

• 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.

• Fiber Optic Blade Laryngoscopes

• Fiberoptic Laryngoscopes

• 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.

• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.

• Gas Scavenging Apparatus (FDA Code: CBN / 868.5430) A gas-scavenging apparatus is a device intended to collect excess anesthetic, analgesic, or trace gases or vapors from a patient's breathing system, ventilator, or extracorporeal pump-oxygenator, and to conduct these gases out of the area by means of an exhaust system.

• Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK / 868.1400) A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

• Gastro-Enterostomy Tube (FDA Code: KGC / 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).

• Heat and Moisture Condenser (FDA Code: BYD / 868.5375) A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

• Hemodialysis Catheter Repair Kit (FDA Code: NFK / 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.

• Home Blood Pressure Monitors

• Hydraulic Cystometric Device (FDA Code: FEN / 876.1620) A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

• I.V. Fluid Transfer Unit (FDA Code: LHI / 880.5440)

• Implanted Hemodialysis Catheter (FDA Code: MSD / 876.5540)

• Implanted Subcutaneous Intraperitoneal Catheter (FDA Code: LLD)

• Implanted Subcutaneous Intravascular Port & Catheter (FDA Code: LJT / 880.5965) A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

• Inflatable Tracheal Tube Cuff (FDA Code: BSK / 868.5750) An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

• Infusion Line Filter (FDA Code: FPB / 880.5440)

• Infusion Pump Accessories (FDA Code: MRZ / 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.

• 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.

• Inspiratory Airway Pressure Meter (FDA Code: BXR / 868.1780) An inspiratory airway pressure meter is a device used to measure the amount of pressure produced in a patient's airway during maximal inspiration.

• Insulin Infusion Pump (FDA Code: LZG / 880.5725)

• Intraspinal Long Term Percutaneous Catheter (FDA Code: LNY)

• Intrauterine Insemination Cannula (FDA Code: MFD / 884.5250) A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.

• Intrauterine Pressure Monitor (FDA Code: KXO / 884.2700) An intrauterine pressure monitor is a device designed to detect and measure intrauterine and amniotic fluid pressure with a catheter placed transcervically into the uterine cavity. The device is used to monitor intensity, duration, and frequency of uterine contractions during labor. This generic type of device may include the following accessories: signal analysis and display equipment, patient and equipment supports, and component parts.

• Intravenous Administration Kit (FDA Code: FPA / 880.5440)