Components: |
Tracheal tube |
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Connector standard size (external Ø 15mm). |
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Fixation flange. |
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Neck tape/band. |
Material: |
Tracheotomy tube: siliconized polyurethane or polyvinyl chloride (PVC) |
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Neck tape/band: adjustable elastic band |
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Tracheostomy tube made of thermo-sensitive PVC; provides sufficient rigidity for initial insertion, and then softens at body temperature to accommodate patient’s anatomy. |
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- Tube: angled +/- 90°, with open atraumatic end. |
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- Fixation flange: anatomic, with all tube size indications. |
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- Built in X-ray radio-opaque line to confirm tube’s position. |
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Attachment system: adjustable collar (cotton) |
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without inner cannula. |
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with or without introduction guide. |
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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. |
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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. |
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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 |
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EN 5366-1:2004 Tracheal tube and connectors |
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EN 1282-2:2005 Tracheostomy tubes - Part 2: Paediatric tubes (ISO 5366-3:2001, modified) |