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DRESSING HYDROCOLLOID, thin, sterile, s.u., small

https://unicat.msf.org/cat/product/73457
STD SDREEAHC3S-

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.
M04040301 - Hydrocolloid dressings, non-combined
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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT25
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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DRESSING HYDROCOLLOID, thin

Definition

A sterile wound covering, typically made of a hydrocolloid intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment.

Specifications

Quality standards

EN 13726-1, 2002, Test methods for primary wound dressings - Part 1: Aspects of absorbency

Technical specifications

  • Three-layer dressing:
    • Polyurethane film semi-permeable to the outside: liquid-tight (sweat, urine, showers) and exogenous contamination, but allowing gas exchange
    • Hydrocolloid based on carboxymethylcellulose (CMC) and gelatin
    • Hypoallergenic adhesive sensitive to pressure and covered with a lining
  • Semi-transparant
  • ​Does not contain antibiotics or antimicrobial substances
  • Absorption capacity: 200 - 300 g / 100 cm² / 24h
  • Absence of latex, absence of rosin (resin with properties of sticking and waterproofing but irritating and allergenic to the skin and the respiratory tract)
  • Easily adapting to anatomical shapes, may be cut to fit.
  • With or without adhesive edge
  • Size +/- 4 x 5 cm
  • Sterile, for single use

Packaging & Labelling

Each dressing is packed in a disposable peel pack allowing effective sterilization, safe handling, and storage of all pouched items until needed for use and facilitating proper aseptic presentation of the material.

(Cf Introduction: Packaging and labelling)

Instructions for use

Precautions for Use

  • Inappropriate use or too frequent changes may cause skin irritation
  • Do not use on heavily exudating or infected wounds
  • Do not use on wounds extending to muscle, tendon or bone and on third degree burns

Storage

  • Store below 25°C
  • Protect from sunlight ‐ Protect from humidity

MSF requirements

To protect the nostrils of small children when nasal prongs are used.

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