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OSTOMY BAG with PLATE, drainable, child

https://unicat.msf.org/cat/product/18267
STD SCTDBACO2P-

Valid Article

Former Code(s): -X -
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).
Article is intended to be used with children (<12 years) ONLY.
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.
A100101 - One piece colostomy 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
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)
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
SC subscriptions: included in supply or field tools
https://unicat.msf.org/web/image/product.template/589521/image_1920?unique=709d5b4

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Ostomy system for child, Pouchkins

Definition

One-piece plastic pouch with a self-adhesive flange designed to be attached around a stoma for use as a receptacle for intestinal output following a colostomy or ileostomy (effluent is typically of a fluid consistency). The distal end of the pouch can be opened for drainage of the waste and emptied several times per day.

Synonym

enterostomy bag

Specifications

Technical specifications

  • One-Piece System: the pouch and skin barrier are a single unit.
  • Bag:
    • flexible, transparent plastic (for easy check)
    • non-woven protection layer on skin side
    • capacity: ±250 ml (paediatric)
    • drainable, with clamp for closure (preferably integrated)
    • active carbon-based anti-odour filter
  • Adhesive disc:
    • diameter to be cut according to the size of the ostomy: up to 38 mm
    • with flat hydrocolloid type skin protector
  • Clamp : reusable rigid clamp or soft adhesive clamp.
  • Single use device
  • Non sterile

Packaging & Labelling

Paediatric size: box of 10

(Cf Introduction: Packaging and labelling)

Supplied with the Article

One adapter included in box which allows the pouch to be connected to a bedside collector

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