| Components: | Tracheal tube | 
|   | Connector standard size (external Ø 15mm). | 
|   | Fixation flange. | 
|   | Neck tape/band. | 
| Material: | Tracheotomy tube: siliconized polyurethane or polyvinyl chloride (PVC)  | 
|   | Neck tape/band: adjustable elastic band | 
|   | Tracheostomy tube made of thermo-sensitive PVC; provides sufficient rigidity for initial insertion, and then softens at body temperature to accommodate patient’s anatomy.  | 
|   | - Tube: angled +/- 90°, with open atraumatic end. | 
|   | - Fixation flange: anatomic, with all tube size indications.  | 
|   | - Built in X-ray radio-opaque line to confirm tube’s position. | 
|   | Attachment system: adjustable collar (cotton) | 
|   | without inner cannula.  | 
|   | with or without introduction guide. | 
|   | Tube size: Nr 4, length 43.2mm, ID 4.0mm,OD 6mm | 
| Unit presentation: | 1 tube, sterile packed in a hard peel-pack container, single-use | 
| Packaging: | Unit presentation: Packed in a hard peel-pack container. Labelling should mention: manufacturer’s name and/or trademark, "sterile", batch/lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body, and the product reference number and description. Must be multilingual: English, French and Spanish, others when available. | 
| Secondary packaging: | Protected unit, one (1) box with 5- or 10-unit presentation, labelling is the same as that of primary packaging. | 
|   | Additional required information: Number of units per secondary packaging, information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.), and user instruction leaflet. Must be multilingual: English, French and Spanish, others when available. | 
| Over packaging: | Packaging unit: strong carton. | 
|   | Each carton and peel pack must be clearly marked with expiry date and batch number. | 
| Other requirements: | Quality must comply with Medical Device Directive 93/42/EEC, risk class IIa | 
|   | EN 5366-1:2004  Tracheal tube and connectors | 
|   | EN 1282-2:2005  Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |