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(drainage, thoracic), VALVE NON RETURN, suction & pressure

https://unicat.msf.org/cat/product/18313
STD SCTDDRTV1--

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.
A0680 - Drainage and fluid collection devices - accessories
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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(thoracic drainage) NON RETURN VALVE

Definition

A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas and fluids into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device.

Synonym

Heimlich chest drain valve, flutter valve, pneumostat valve

Specifications

The design of the flutter valve features a rubber sleeve in a plastic case, where the rubber sleeve is arranged so that when air flows through the valve the sleeve opens and allows the outwards airflow from the body of the patient; however, when the airflow is reversed, the rubber sleeve closes and halts backwards airflow into the body of the patient.

Image

Quality standards

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

Technical specifications

  • Cylindrical device with single or double chamber
  • Transparent, semi-rigid plastic
  • Non return system: 2 flat, tubular sleeves made of natural rubber
  • Arrow showing the direction of flow (lung => container)
  • Distal (patient) end with connector for connecting to the thoracic drain
  • Proximal end with connector for connecting to the collecting tube
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

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Precautions for Use

The use of a urine bag is contra-indicated since once filled with liquid or air, it blocks the suction system, which can quickly lead to critical outcomes.

If the use of a urine bag is unavoidable, it is mandatory to make large perforations in the top of the bag before using it to allow the air to be evacuated.

Storage

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

MSF requirements

Required for the thoracic drainage system recommended by MSF.

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