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REDON, 400-600ml, + alene needle/drain CH 12, ster. s.u.

https://unicat.msf.org/cat/product/18372
STD SCTDREDP412

Valid Article

Former Code(s): -X
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.
A060101 - Vacuum and gravity drainage systems
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
CT3+
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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REDON, bellows

Definition

A collection of sterile devices designed to remove fluids or purulent material from a closed-wound in a controlled manner. It includes a container (the receptacle or reservoir), drains/catheters, connectors and a trocar for placing the drains/catheters into the site.

The reservoir is provided with markers at increments along its side to facilitate the approximate measurement of the collected fluids. It can be used for a wide range of surgical applications.

Specifications

Quality standards

ISO 20697, 2018, edition 1, (confirmed 2023) Sterile drainage catheters and accessory devices for single use

Technical specifications

Complete system including 4 items:

  • REDON or ALENE NEEDLE
    • austenitic stainless steel containing molybdenum
    • solid curved needle: straight part +/-15 cm, curved part +/- 19 cm
    • distal end with taper or cutting point
    • PVC point protection
    • threaded base enabling it to be screwed to the drain or attached to the drain
  • REDON DRAIN
    • soft PVC, kink resistant
    • ​with radio-opaque line
    • multiperforated distal (patient) end over 7 - 15 cm
    • proximal end connected to the connecting tube
    • overall length: ± 50 cm
    • external diameter: CH12 or CH16
  • CONNECTING TUBE
    • PVC, etc.
    • connects the drain to the collecting bottle
    • fitted with a clamp
    • length: ± 100 cm
  • COLLECTING BOTTLE
    • polyethylene, etc.
    • accordion-shaped
    • graduated
    • capacity: 450 - 600 ml
    • fitted with a non-return device

The whole system is sterile and for single use.

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Mechanical device used for the active drainage of surgical wounds through negative pressure.

Storage

  • Store below 30°C
  • Protect from sunlight ‐ Protect from humidity
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