General information
To evacuate liquids or gases from the pleural cavity.
Underwater seal chest drainage bottle.
Used after chest surgery or a chest trauma; i.e., pneumo-haemotothorax, empyema.
Specifications
Materials:
Instruments: high-grade polymer
Description:
Set content:
1 plastic tray
1 pair of surgical gloves, size 7.5
1 drape, 45x75cm
1 whole towel, 75x110mm, blue
2 gauze compresses with slit, 10x10cm, 12-fold (ply)
5 gauze compressed, 10x10cm, 12-fold (ply)
1 disposable scalpel, size 11
1 disposable Metzenbaum dissecting scissors, curved, 180mm
1 disposable needle holder: Mayo-Hegar, 150mm
1 disposable tubing clamp, 135mm
1 suture Miralene 2/0, 75cm, 1xDS39
(Manufacturer Bbraun: Ref SUSI: 5062000)
All instruments are single use (Brand name Suzi); they cannot be re-sterilized.
All materials can be incinerated as part of a hospital’s regular waste removal system.
Unit presentation:
1 set, sterile, single-use, double packaged, peel pack
Primary packaging:
Must be supplied in 2 layer packaging, outer layer in a peel pack.
Labelling should mention:
Name and/or trademark of the manufacturer, "sterile", lot number, expiry date by year and month, "for single use", product description, instructions for use, and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.
Secondary packaging:
Protected unit, one (1) box with 5-unit presentation, labelling is the same as primary packaging.
Additional required information: Number of units per secondary packaging.
Storage:
Should be stored at a maximum temperature of 25°C.
Norms:
Complies with Medical Device Directive 93/42/EEC
CE mark and reference number of notifying body.