Tube, rectal

last updated : 2018/12/31
Code Description Budget Price Ship. weight Ship. vol.
MCTDTREC25
TUBE, rectal, CH 25, disposable CH 0.29 1.65kg 8,775L Add
Item to be justified
MCTDTREC28
TUBE, rectal, CH 28, disposable CH 0.29 0kg 0 Add
Item to be justified
MCTDTRECIRRI
IRRIGATOR, RECTAL, plastic, complete w/tubing on request 0kg 0 Add

General information

To apply an enema into the rectum.

To release gas from the rectum.

Specifications

A flexible hollow tube used to access the rectum for irrigation.

Materials:

Polyvinyl chloride (PVC), medical grade.

Description:

- Consists of a hollow cylindrical tube with a central channel for rectal infusion or drainage.

 

- At patient end: tip has central opening with soft round edges

 

- At proximal end: funnel or cup connector (conical tip)

 

- Size: length 30-40cm, diameter CH25

 

- Sterilization: either ethylene oxide gas or gamma  radiation.

Unit presentation:

1 tube, sterile, single-use, peel pack.

Primary packaging:

Must be supplied in sterilized peel pack sachets. Labelling should mention: manufacturer’s name and/or trademark. "sterile", lot number, expiry date by year and month, "for single use", CE mark and 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, 1-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.).

Quality:

Norms: Must comply with:

 

- Medical Device Directive 93/42/EEC, risk class II a

 

- EN 550 gas sterilization ethylene oxide

Unit presentation:

1 tube, sterile, single-use

Packaging:

Primary packaging: Must be supplied in a sterile peel pack. Labelling should mention: manufacturer’s name and/or trademark. "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number of 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 xxxx -unit presentation; labelling is the same as that of primary packaging.

Additional required information:

Number of units per secondary packaging and information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).

Other requirements:

Quality must comply with Medical Device Directive 93/42/EEC.