Tube, tracheotomy, without cuff, paediatric

last updated : 2018/12/31
Code Description Budget Price Ship. weight Ship. vol.
MCTDTTRA03
TUBE, TRACHEOTOMY, No 3.0 without cuff, sterile, s.u. CH 19.55 0.3kg 4,048L Add
Item to be justified
Controlled Temp : Storage +15 to +25°C
MCTDTTRA04
TUBE, TRACHEOTOMY, No 04, without cuff, sterile, disposable CH 2.70 0.001kg 0,63L Add
Controlled Temp : Storage +15 to +25°C
MCTDTTRA05
TUBE, TRACHEOTOMY, No 05, without cuff, sterile, disposable CH 2.90 0.018kg 0,639L Add
Controlled Temp : Storage +15 to +25°C

General information

For insertion into the trachea via an incision in the neck (tracheotomy) in order to maintain a clear airway and to shorten airway "dead space".

Specifications

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)