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SODIUM chloride 6%, for nebulizer, 4 ml, vial

https://medicalguidelines.msf.org/en/node/1198
https://unicat.msf.org/cat/product/12301
STD SSCOSODC6V-

Valid Article

Former Code(s): DORASODC6V-
The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
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.
R060203 - Inhalation therapy humidification liquids
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
1525
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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SODIUM chloride 6% for nebilization

Definition

A sterile, hypertonic saline solution, consisting only of water and sodium chloride (> 0.9% NaCl) intended to be used for the induction of sputum in a patient, via physiological osmotic mechanisms. It is intended to be used with a nebulizer to produce a mist that can be inhaled into the lungs where cells lining the airways are triggered to release water and facilitate restoration of the layer of moisture lining the airways for clearing of mucous. The solution is typically available in a single unit-of-use container. This is a single-use device.

Specifications

Technical specifications

  • 4ml hypertonic sodium chloride inhalation solution (NaCl 6%)
  • sterile solution

Instructions for use

Sputum induction in children : administer hypertonic sodium chloride solution with a nebulizer and a mask (see related articles below).

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Storage

Below 25°C

MSF requirements

Used for induction of sputum in a patient in order to obtain a sample for laboratory analysis.

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