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SODIUM chloride, 0.9%, 500ml, plast. bot.,irrigation,sterile

https://unicat.msf.org/cat/product/40823
STD SSCOSODC9B5

Valid Article

Former Code(s): DEXTZBD0029 DEXTSODC9B5
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 for irrigation

Definition

A sterile solution of sodium chloride (NaCl), intended to be used to irrigate and clean a wound, wound dressing, or surgical site; it may in addition be intended for non-patient-contact applications (e.g., device irrigation). It is not intended to provide antimicrobial activity and is typically provided in an appropriate container. After application, this device cannot be reused.

Specifications

Technical specifications

  • 100 ml of 0.9% Sodium Chloride Irrigation (USP) contains sodium chloride 900 mg, water for Injection USP qs.
  • pH 5.6 (4.5 — 7.0)
  • isotonic solution (308 mOsmol/liter, calculated)
  • electrolyte content (mEq/liter):
    • Na+ 154
    • Cl¯ 154
  • no bacteriostatic, antimicrobial agent or buffer added
  • solution is sterile, for single use
  • semi-rigid bottle with screw cap
  • volume: 500 ml

Packaging & Labelling

The plastic bottle is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers. The bottle is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration.

Instructions for use

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Precautions for Use

  • Aseptic technique is essential with the use of sterile solutions for irrigation
  • An electrolyte solution should not be used for irrigation during electrosurgical procedures.
  • Not for injection by usual parenteral routes
  • Do not warm above 66°C
  • After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
  • Discard unused portion of irrigating solution since it contains no preservatives.

Storage

Read the manufacturer's instructions on the packaging.

  • Exposure of pharmaceutical products to heat should be minimised. Avoid excessive heat.
  • Protect from freezing.
  • It is recommended that the product be stored at room temperature (between 15 and 25°C); however, brief exposure up to 40°C does not adversely affect the product.

MSF requirements

Sterile physiological water in a semi-rigid plastic bottle presentation allowing to irrigate and clean a wound, a wound dressing, or a surgical site.

Is included in the modular hospital kit

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