Materials: |
Tube: Transparent polyvinyl chloride (PVC) or polyurethane. |
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Connector: PVC |
Description: |
Tracheal tube and connector without cuff. |
Components: |
- Tube: Murphy type, curved. |
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- Nasal or oral, 37.5° angle. |
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- Continuous X-ray line. |
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- Graduated. |
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- Patient end: open and bevelled (obliquely cut), atraumatic, black tip, with position indicator for correct tube placement. |
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- Connector: straight double-ended: |
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Machine end: standard male connector, conical, straight, outer |
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Ø 15mm for connecting a breathing circuit or manual resuscitator. |
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Patient end: a long plain axis, length and diameter selected according to the tube size to ensure a safe fitting (refer to sizes below). |
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Tube sizes plus connector part: patient end |
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- Nr 2.5: minimum length 140mm, ID 2.5 mm, OD 3.3mm |
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Connector, patient end: minimum 9mm |
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- Nr 3.0: minimum length 160mm, ID 3.0 mm, OD 4.0mm |
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Connector, patient end: minimum length 9mm |
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- Nr 4.0: minimum length 200mm, ID 4.05 mm, OD 5.3mm |
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Connector, patient end: length minimum 11mm |
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- Nr 5.0: minimum length 250mm, ID 5.0 mm, OD 6.7mm |
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Connector, patient end: length minimum 12mm |
Unit presentation: |
1 endotracheal tube: sterile, single-use, peel pack. |
Packaging: |
Primary packaging: Sterile peel pack. |
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Labelling should indicate: Manufacturer’s name and trademark, "sterile", lot number, expiry date by year and month, "for single use", CE mark plus reference number for notifying body, product description and instructions for use. Must be multilingual: English, French and Spanish, others when available.. |
Secondary packaging: |
Protected unit, one (1) box with a 10-unit presentation, labelling same as primary packaging. |
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Additional required information: Number of units per secondary packaging and information for product-specific storage conditions. |
Storage: |
Store in clean dry conditions; keep away from light and heat. |
Other requirements: |
Complies with Medical Device Directive 93/42/EEC, risk class IIa. |
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Meets following norms: |
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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) |