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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• Irrigation Catheter (FDA Code: GBX / 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.

• Laryngectomy Tube (FDA Code: KAC / 874.4420)

• Laryngoscopes

• Laryngoscopes, Intubation System

• Manual Emergency Ventilator/Resuscitator (FDA Code: BTM / 868.5915) A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

• Measuring Gauge (FDA Code: JYJ / 874.4420)

• Mechanical Ventilators

• Monitoring Equipment

• Multiparameter Monitors

• Multiparameter Monitors

• Nasal Airways

• Nasal Cannulas

• Nasal Endotracheal Tubes

• Nasopharyngeal Airways (FDA Code: BTQ / 868.5100) A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway.

• Neonatal Apnea Monitor (FDA Code: FLS / 868.2377) An apnea monitor is a complete system intended to alarm primarily upon the cessation of breathing timed from the last detected breath. The apnea monitor also includes indirect methods of apnea detection such as monitoring of heart rate and other physiological parameters linked to the presence or absence of adequate respiration.

• Neonatal Multiparameter Monitors

• Non Self-Inflating Manual Resuscitator (FDA Code: NHK / 868.5905) A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.

• Non-Continuous Ventilator/Respirator (FDA Code: BZD / 868.5905)

• Non-Electromagnetic Radiation Blood Warmer (FDA Code: BSB / 864.9205) A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

• Non-Implanted Hemodialysis Catheters (FDA Code: MPB / 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.

• 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-Measuring Exerciser (FDA Code: ION / 890.5370) Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.

• Non-Powered Portable Single Patient Suction Apparatus (FDA Code: GCY / 878.4680) A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.

• Non-Rebreathing Oxygen Mask (FDA Code: KGB / 868.5570) A nonrebreathing mask is a device fitting over a patient's face to administer oxygen. It utilizes one-way valves to prevent the patient from rebreathing previously exhaled gases.

• Non-Rebreathing Valve (FDA Code: CBP / 868.5870) A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

• Nuclear Medicine

• Nuclear Medicine Accessories

• Nuclear Medicine Consulting Service

• Nuclear Medicine Service

• Oral Airways

• Oral Airways, Emergency Pack

• Oral Cannulas

• Oral Endotracheal Tubes

• Orthostatic Vital Signs Monitors

• 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.

• Oximetry

• Oxygen Masks (FDA Code: BYG / 868.5580) An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols.

• Oxygen Nasal Cannula (FDA Code: CAT / 868.5340) A nasal oxygen cannula is a two-pronged device used to administer oxygen to a patient through both nostrils.

• Patient Controlled Analgesia (PCA) Infusion Pump (FDA Code: MEA / 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.

• Patient Physiological Monitor without Arrhythmia Detection (FDA Code: MWI / 870.2300) A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

• Pediatric Urine Collector (FDA Code: KNX / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Pediatric Vital Signs Monitors

• Percutaneous Catheterization Vessel Dilator (FDA Code: DRE / 870.1310) A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.

• Peristaltic Infusion Pump (FDA Code: FRN / 880.5725)

• 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.

• Pleural Catheter with Flexible Introducer

• Powered Electric Percussor (FDA Code: BYI / 868.5665) A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.

• Powered Emergency Ventilator/Resuscitator (FDA Code: BTL / 868.5925) A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.

• 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.

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.