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URINE BAG 2 l, drain., non-ret. valves, sampling port, ster.

https://unicat.msf.org/cat/product/76860
STD SCTDBAGU2VSS

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.
A06030301 - Urine collection bags
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
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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URINE COLLECTION BAG, with sampling port

Definition

A sterile flexible plastic pouch designed to connect to a urinary catheter to collect discharged urine from a patient. It is designed with an opening for urine drainage and a needle-free sampling port. The device is not directly attached to the patient.

Specifications

Quality standards

ISO 8669-2, 1996, edition 2, (confirmed 2023) Urine collection bags - Part 2: Requirements and test methods

Technical specifications

  • Bag:
    • flexible, transparent plastic
    • capacity: 2 litres
    • graduations every 100 ml
    • non-return valve at the tube inlet
    • emptying system (T-shaped drainage tap)
    • integrated hanging eyelets
  • Drainage tube:
    • flexible plastic
    • length: ± 90 cm, d​iameter: 6 to 9 mm
    • universal connector for connecting to a catheter, a urostomy pouch or a condom catheter/ incontinence sheath
    • needle-free sampling port
    • protective cap
  • Inside AND outside are sterile
  • For single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

Please consult the “Manual of nursing Care Procedures, MSF, 2020” available online via the Nursing care working Group sharepoint page.

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Precautions for Use

The drainage system should not be disconnected because this increases the risk of bacterial contamination. The catheter and the bag should be removed together.

It is important that samples are not taken from the bag (tap) because of multiplication of micro-organisms within this reservoir causing higher numbers. If no urine is visible in the tubing clamp it a few centimetres below the sampling port (do not clamp the catheter itself!). Wait until sufficient urine collects before proceeding with the sampling.

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