Profile: Maquet Inc. designs equipment and disposables for cardiac surgery. We provide products for ventilation, perfusion systems, cardiac surgery and cardiopulmonary products. We also produce different types of operating tables and lights.

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• AC-Powered Medical Examination Device (FDA Code: KZF / 880.6320) An AC-powered medical examination light is an AC-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.

• AC-Powered Operating Room Table (FDA Code: FQO / 878.4960) Operating tables and accessories and operating chairs and accessories are AC-powered or air-powered devices, usually with movable components, intended for use during diagnostic examinations or surgical procedures to support and position a patient.

• Anesthesia Gas-Machine (FDA Code: BSZ / 868.5160) A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.

• Anesthesia System

• Anesthesia Table and Tray Cabinet (FDA Code: BRY / 868.6100) An anesthetic cabinet, table, or tray is a device intended to store anesthetic equipment and drugs. The device is usually constructed to eliminate build-up of static electrical charges.

• Arrhythmia Detector and Alarm (FDA Code: DSI / 870.1025) The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

• Arterial Filters

• Artery Vascular Clamp (FDA Code: DXC / 870.4450) A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

• Beating Heart Stabilizers

• Breathing Circuit Bacterial Filter (FDA Code: CAH / 868.5260) A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.

• Bubble Trap

• Capnograph

• Cardioplegia Cannulae

• Cardioplegia Heat Exchangers

• Cardiopulmonary Bypass Heart-Lung Machine Console (FDA Code: DTQ / 870.4220) A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

• Cardiopulmonary Bypass Temperature Controller (FDA Code: DWC / 870.4250) A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

• Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN / 868.6175) A cardiopulmonary emergency cart is a device intended to store and transport resuscitation supplies for emergency treatment. The device does not include any equipment used in cardiopulmonary resuscitation.

• Cardiovascular Surgical Instrument (FDA Code: DWS / 870.4500) Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

• Cardiovascular Systems

• Ceiling Mounted Surgical Light (FDA Code: FSY / 878.4580) A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

• Clampless Proximal Anastomosis Devices

• Continuous Vacuum Regulators

• Continuous Ventilator (FDA Code: CBK / 868.5895) A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

• Coronary Artery Perfusion Cannulae with Balloon

• Diagnostic Capnographs

• Digital Vacuum Regulator

• 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.

• Electronic Gas Blenders

• Electrosurgical Cutting and Coagulation Device (FDA Code: GEI / 878.4400) An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

• Embolic Agents For Treatment Of Uterine Fibroids (FDA Code: NAJ / 870.3300)

• End-tidal Carbon Dioxide Monitors

• Endoscopic Smoke Removal Tube (FDA Code: FCZ / 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.

• Endoscopic Television Camera without Audio (FDA Code: FWF / 878.4160) A surgical camera and accessories is a device intended to be used to record operative procedures.

• Endoscopic Vessel Harvesting System

• Endoscopic Visualization Systems

• Environmental Control Filters

• Equipment Stands & Carts

• Extracorporeal Membrane Oxygenation (ECMO) Cannulae

• Floor Standing Surgical Light (FDA Code: FSS / 878.4580)

• Gaseous Phase Oxygen Gas Analyzer (FDA Code: CCL / 868.1720) An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500)

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Heart Stabilizer (FDA Code: MWS / 870.4500)

• 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.

• High Three-Mode Continuous Vacuum Regulators

• 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.

• Intraprocedural Equipment

• 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.

• Left Heart Vent Catheters

• Low Two-Mode Continuous Vacuum Regulators