DEVICE: Atos Medical (00817126020894)

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.

A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.

An electrically-powered device designed for the in vitro irradiation of blood and/or blood components with ultraviolet (UV) radiation, typically used in blood banks for the prevention of transfusion-associated transmission of pathogens, or in healthcare facilities for off-line photoimmunotherapy of a leukocyte-enriched blood fraction as a treatment for cutaneous T-cell lymphoma [CTCL]. It operates off-line (i.e. the blood is not returned to the patient in a closed circuit) and consists of a cabinet chamber and a source of UV light (UVA, B, or C is used according to intended use), and may also include tubes and pumps for continuous flow processing.