BALLOON, ANAESTHESIA, Ø 22 mm, 3 l

STD EANEBALA3--

Valid Article

Former Code(s): -X
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
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
The order of this product needs to be justified and is only acceptable under certain conditions.
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SC subscriptions: included in supply or field tools
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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
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