PERISTOMAL POWDER, 25-30 g, squeeze bottle

STD SCTDBACODP1-

Valid Article


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.
A108003 - Protective powders for peristomal skin
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.
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 order of this product needs to be justified and is only acceptable under certain conditions.
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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Peristomal powder

Definition

A non-sterile substance or material intended to be applied to peristomal and/or periwound skin intended to protect it from body effluent (e.g., faeces, urine, wound exudate) and/or to help secure the wound dressing. The device is available as powder.

Specifications

This powder is an accessory to an ostomy pouching system intended to absorb excess moisture from the skin around a stoma to allow the baseplate to adhere to the skin.

Instructions for use

Sqeeze gently to apply a light dusting of powder to the skin around the stoma. Remove excess powder.

Precautions for Use

Do not use if the skin surface around the stoma is dry because the powder may interfere with baseplate adhesion.

Storage

Store in a cool and dry space.

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