BALLOON, ANAESTHESIA, Ø 22 mm, 1 l
STD
EANEBALA1--
Valid Article
Account code:
60100
HS Code:
903300
Last Updated on:
02/05/2024, 22:07:11
R03020101 - Anaesthesia balloons
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
BALLOON, ANAESTHESIA, latex-free
Definition
A non-sterile elastomeric reservoir sac intended to store breathing gas during the respiratory cycle used in anaesthesia or ventilator breathing circuits. The breathing bag may be on the inspiratory or expiratory limb of a breathing circuit depending on the breathing circuit design. It may also function as a maximum pressure limiting device during spontaneous or manually assisted ventilation. This is a reusable device.
Synonym
Rubber bladder
Specifications
Quality standards
ISO 5362, 2006, edition 4, (confirmed 2016) Anaesthetic reservoir bags
Technical specifications
- Resistant and supple material (silicone, neoprene), latex free and antistatic
- Rigid normalised connection 22F
- Terminal tip with teat or ring-shaped (allowing to hang up the ballon for drying after cleaning and predisinfection procedures)
- Capacity: 1 litre or 3 litres (must appear on the balloon)
- Autoclavable
- Non sterile
Instructions for use
Autoclavable. Follow the MSF sterilisation protocols.
(Cf Introduction: Disinfection and sterilization in the field)
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