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BALLOON, ANAESTHESIA, Ø 22 mm, 1 l

https://unicat.msf.org/cat/product/12491
STD EANEBALA1--

Valid Article

Former Code(s): -X
Article is intended to be used with children (<12 years) ONLY.
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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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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