SODIUM chloride, 0.9%, sterile, 5ml, unidose, amp.

STD SSCOSODC9A5

Valid Article

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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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, 0.9%, sterile, 5ml, unidose, amp.

This product replaces the following articles:

  • SODIUM CHLORIDE 0.9%, eye drops, sterile, 0.5ml (DEXOSODC9D05), and
  • PHYSIOLOGICAL SALINE SOLUTION, NaCl, 0.9%, 5 ml, plas. vial (SLASSODC9B5)

Definition

A water-based salt solution (e.g., sodium chloride isotonic solution) intended for alternative use in multiple patient applications including inhalation therapy, moisturizing and washing/irrigation of the eyes, nose and ears, and wound cleansing; it is not dedicated to a specific application or part of the anatomy. It is typically available in a squeeze bottle for self-administration or application to infants for preventive or symptomatic care in the home. After application, this device cannot be reused.

Synonym

Normal saline, 0.9%, sterile, Sterile saline solution, 0.9%

Specifications

Technical specifications

  • 0.9% Sodium chloride equivalent to 900 mg of sodium chloride per 100 ml of water for injection (USP)
  • isotonic solution
  • preservative-free
  • sterile solution
  • unidose, plastic container (ampoule) for single use
  • volume: 5 ml

Instructions for use

For laboratory use (general and bacteriology), please consult the “Updated laboratory procedures, 2022” or “Bacteriology laboratory procedures and resources“ available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.

https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Home.aspx

For offline access, contact your laboratory advisor.

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Precautions for Use

Do not administer via parenteral routes.

Do not swallow.

Follow aseptic techniques when using sterile solutions for irrigation.

Storage

  • Below 25ºC
  • Do not refrigerate or freeze.
  • Discard any unused remaining solution since it contains no preservatives.
  • Read the manufacturer's instructions on the packaging.
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