Tube, tracheotomy, with cuff

last updated : 2018/12/31
Code Description Budget Price Ship. weight Ship. vol.
MCTDTTRA06C
TUBE, TRACHEOTOMY, No 06, with cuff, sterile, disposable CH 3,13 0,046kg 0,81L Add
Controlled Temp : Storage +15 to +25°C
MCTDTTRA07C
TUBE, TRACHEOTOMY, No 07, with cuff, sterile, disposable CH 2,87 0,056kg 0,832L Add
Controlled Temp : Storage +15 to +25°C
MCTDTTRA08C
TUBE, TRACHEOTOMY, No 08, with cuff, sterile, disposable CH 3,12 0,037kg 0,345L Add
Controlled Temp : Storage +15 to +25°C
MCTDTTRA09C
TUBE, TRACHEOTOMY, No 09, with cuff, sterile, disposable CH 2,62 0,039kg 0,345L Add
Controlled Temp : Storage +15 to +25°C
MCTDTTRA10C
TUBE, TRACHEOTOMY, No 10, with cuff, sterile, disposable CH 3,16 0kg 0 Add
MCTDTTRASM04
TRACHEOSTOMY SET, MINI, tube diam. 4.0, disposable, sterile on request 0kg 0 Add

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:

 

Cuff and balloon: low pressure.

 

External pilot balloon and pressure cuff indicator.

 

Connector, standard size (external Ø 15mm).

 

Fixation flange.

 

Neck tape and band

Materials:

Tracheotomy tube: siliconized polyurethane or polyvinyl chloride (PVC).

 

Neck tape and 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.

 

The tracheotomy tubes are standardized in terms of dimensions.

 

Tracheal tube.

 

Tube: angled +/- 90°, with open atraumatic end.

 

Tracheal cuff  and balloon: located near the distal end:

- Prevents air leakage and stomach aspiration.

 

- Profile (high volume, low pressure) cuff. The cuff dynamically adjusts the pressure and points of contact during the breathing cycle, minimizing the potential for tracheal trauma.

 

- Connector: tube proximal end with standard connection (external Ø 15mm)

 

- Fixation flange: with all tube size indications.

 

- External pilot balloon: indicates cuff’s inflation status and is connected to a shut-off valve/ non-return valve to maintain the requested pressure in the trachea; connection for syringe: Luer tip.

 

- Built in X-ray radio-opaque line to confirm the tube’s position.

 

Attachment system: adjustable collar (cotton).

 

No inner cannula.

 

Tube size: Nr 6, length 64mm, ID 6.5mm, OD 8.7mm, cuff Ø 19mm

 

Tube size: Nr 7, length 70mm; ID 7.5mm, OD 10mm, cuff Ø 21mm

 

Tube size: Nr 8, length 81mm; ID 8.5mm, OD 11.3mm, cuff Ø 28mm

 

Tube size: Nr 9, length 87mm; ID 9.5mm, OD 12.7mm, cuff Ø 28mm

 

Individual sterilized peel packs made of paper and/or plastic.

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", CE mark and reference number of notifying body, and 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.

Outer packaging:

Packaging unit strong carton.

Quality requirements:

Must comply with Medical Device Directive 93/42/EEC, risk class IIa  requirement.

 

Meets norm EN 1282-1:  Anaesthetic and Respiratory Equipment

 

Tracheostomy Tubes Part 1: Tubes for Use in Adults

 

EN ISO 5366-1:2004 Anaesthetic and respiratory equipment.

 

Tracheostomy tubes. Tubes and connectors for use in adults