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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• Manual Obstetrical Table and Accessories (FDA Code: HHP / 884.4900) An obstetric table is a device with adjustable sections designed to support a patient in the various positions required during obstetric and gynecologic procedures. This generic type of device may include the following accessories: patient equipment, support attachments, and cabinets for warming instruments and disposing of wastes.

• Mechanical Noninvasive Ventilators

• Mechanical Ventilation Circuits

• Mechanical Ventilator Monitors

• Mechanical Ventilators

• Mobility Products & Aids

• Multilevel PAP (Positive Airway Pressure) Systems

• Nebulizers

• Neurovascular Embolization Device (FDA Code: HCG / 882.5950)

• Non-Roller Type Cardiopulmonary Bypass Blood Pump (FDA Code: KFM / 870.4360) A nonroller-type cardiopulmonary bypass blood pump is a device that uses a method other than revolving rollers to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.

• Patient Physiological Monitor (FDA Code: MHX / 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.

• Pediatric Catheter

• Polymeric Surgical Mesh (FDA Code: FTL / 878.3300) Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Polypropylene PTFE PETP Pledget and Intracardiac Patch (FDA Code: DXZ / 870.3470) An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.

• Portable Air Compressor (FDA Code: BTI / 868.6250) A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.

• Pressure Monitoring Catheters

• Quality Control Kits (FDA Code: JTR / 866.2480) A quality control kit for culture media is a device that consists of paper discs (or other suitable materials), each impregnated with a specified, freeze-dried, viable microorganism, intended for medical purposes to determine if a given culture medium is able to support the growth of that microorganism. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Servo Ventilators

• Small Diameter Vascular Graft Prosthesis (FDA Code: DYF / 870.3450) A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.

• Specified Concentration Calibration Gas (FDA Code: BXK / 868.6400) A calibration gas is a device consisting of a container of gas of known concentration intended to calibrate medical gas concentration measurement devices.

• Standard Three-Mode Continuous Vacuum Regulators

• Standard Two-Mode Continuous Vacuum Regulators

• Surgical Cutter (FDA Code: FZT / 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.

• Surgical Light Accessories (FDA Code: FTA / 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.

• Surgical Tables Accessories, Infusion Stand

• Surgical/Free-Flow Vacuum Regulator

• Synthetic/Biological Composite Vascular Graft (FDA Code: MAL / 870.3450)

• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Temporary Pacing Electrodes

• Thoracic Drainage Catheters

• Thoracic Vacuum Regulator

• Vacuum Collection Bottle (FDA Code: KDQ / 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).

• Vacuum Regulator (FDA Code: KDP / 880.6740)

• Vacuum Regulator Color Coding

• Vacuum Regulator Repair

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

• Vascular Device for Promoting Embolization (FDA Code: KRD / 870.3300)

• Vascular Graft Prosthesis (FDA Code: DSY / 870.3450)

• Venous Bubble Traps

• Venous Return Catheters

• Ventilators

• Wall Vacuum-Powered Operating Room Suction Apparatus (FDA Code: GCX / 880.6740)

• Water Jet Lavage Unit (FDA Code: FQH / 880.5475) A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.

• Wound Management Pouching Systems