General information
For collecting stools from a patient with a colostomy (artificial anus).
Specifications
The colostomy pouch is one piece open system, with deodorising filter and pre-cut opening.
It is a medical device that consists of a bag attached to the patient’s skin by an adhesive material.
The pouch is drainable from the bottom and kept closed by a removable safety clamp.
Material:
Bag:
Polyvinyl chloride (PVC)
Low density polyethylene (LDPE)
Ethylene vinyl acetate (EVA)
Filter:
Charcoal granulates
Clip
Plastic
Description:
Made of flexible transparent plastic with a non woven protection layer on skin side
Shape:
Anatomical shaped with smooth edges
Adhesive attachment system:
12 x 12cm, with hydrocolloid skin protector, to ensure, safe continuity between bag and colostomy.
Size:
Length 19 x width 14 cm with:
- Window/aperture: starts at Ø +/- 14mm then pre-cut marking up to 64mm
- Pre-cut marking: 25/38/51 and 64mm
for absorbing gases and unpleasant smell produced by bowels.
Clip:
with secure closing system
Unit presentation:
one colostomy bag, hygienically clean, single use.
Packaging:
- colostomy bags in boxes of 10/ 20 pieces according to supplier
closing clip by 20 pieces
Each carton to be clearly identified with product name & characteristics, manufacturer addressee, lot No, number of units per carton and multilingual user manual.
CE marked.
Storage:
protected from light and humidity
Other requirement
Quality complies with Medical Device Directive 93/42/EEC.