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DRAIN, THORACIC, sterile, s.u., CH12

https://unicat.msf.org/cat/product/18307
STD SCTDDRTH12-

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.
A0601010401 - Thoracic drainages (straight and angled)
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
PM
The order of this product needs to be justified and is only acceptable under certain conditions.
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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THORACIC DRAIN

Definition

A sterile flexible tube intended for percutaneous introduction into the pleural for intermittent or long-term drainage. It is designed to be connected to a pleural cavity suction (drainage) system. The thoracic drain comes without trocar.

Specifications

Quality standards

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

Technical specifications

  • tubular drain in PVC (may contain phthalates-DEHP) or silicone
  • straight
  • open distal end
  • perforated: atraumatic lateral eyes
  • radio-opaque
  • depth markings after side eyes: every 2 cm or at 5cm and 10cm
  • proximal end: PVC or ABS standard connection
  • length: 25 to 50 cm
  • sterile, for single use

Packaging & Labelling

Sterile double package: inner pouch in plastic film and external pouch in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Each drain must be ordered with 1 non-return valve + 2 drainage bottles + 1 silicone tube + 1 biconical connector (see related articles below)

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Storage

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

MSF requirements

Required for the thoracic drainage system recommended by MSF. The choice has been made to supply the thoracic drain without trocar for safety reasons.

It is preferable to order separate thoracic drains with a non return-valve, draining bottles, silicone tubing and biconal connectors than to order the complete thoracic drainage set. The complete set is expensive and only reserved for emergency situations.

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