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  3. DRAINAGE POUCH, 10x20cm, 1900ml, window, ster. s.u.
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DRAINAGE POUCH, 10x20cm, 1900ml, window, ster. s.u.

https://unicat.msf.org/cat/product/76875
STD SCTDBAWD2--

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.
A060301 - Collection bags and other containers for drainage and fistulas, single use
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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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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WOUNDPOUCH, drainable

It is possible that not all sizes are available at all times, please contact your supply centre for exact information about availability.

Definition

A sterile plastic pouch designed to be attached to the skin around a large wound or fistula and intended to be used as a receptacle for exudate, blood, or other bodily wastes. It is a one-piece device, with a large-area adhesive flange that can be cut to fit closely around a wound, and which provides some skin protection. It has a tubular outlet to be connected to a drain system.

Specifications

Quality standards

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

Technical specifications

One-piece sterile, single use device with adhesive base plate (wafer) and collection pouch (similar to a large one-piece stoma bag)

Can remain in place up to 7 days.

BASE PLATE

  • Pliable flat base plate with adhesive properties
  • Opening should be able to be cut to various shapes (cut-to-fit)
  • Composition of hydrocolloid material that protects the skin and wound edges from corrosive fistula output

POUCH

  • Transparent pouch with at least one dependent drainage opening that can be closed-off fluid-tight and allows connection via conical connection piece to a drainage bag (e.g. standard urine bag)
  • With hinged access window to allow for inspection or dressing of the wound
  • Capacity: minimum 450 ml ( SCTDBAWD1--and SCTDBAWD3--) or 1900 ml (SCTDBAWD2--)

To be Ordered Separately

Peristomal dressing rings are quite effective in making irregular perifistular surfaces, smoother, hence facilitating adhesion of the pouches; they also allow irritated surrounding skin to heal as they work as a barrier seal between the edge of the fistula/wound and the bag wafer. They can be moulded and reshaped to fit irregular and odd-shaped lesions.

MSF requirements

The large pouch can be used for the treatment of open abdomen while the small one is used for fistula care.

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