OSTOMY BAG 190ml + PLATE 0-22mm, drainable, Neonate

STD SCTDBACO3N1

Valid Article


Single patient multiple 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.
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.

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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Ostomy system, neonate, Pouchkins

Definition

A plastic pouch 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). It consists of two separate parts including the pouch with a flange and a base plate, both having a flange locking mechanism. The distal end of the pouch can be opened for drainage of the waste and emptied, e.g., several times per day. This is a single-use device.

Synonym

enterostomy bag

Specifications

This pouching system is designed for small infants.

The skin barrier and pouch are separate and need to be assembled to be used as a one-piece pouching system.

The SoftFlex™ barrier is a standard wear skin barrier that is gentle to the skin.

The pouch has a drain tap at the bottom, which is compatible with a Luer-Lock syringe, which makes emptying easier when drainage is liquid. The bottom of the pouch may be cut off and a soft wire closure can be added at the bottom.

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Technical specifications

baseplate:

  • with protective skin layer
  • opening not pre-defined: to cut according need (up to 35 mm x 22 mm)

bag / pouch:

  • transparent
  • odor-proof
  • length: 16 cm
  • capacity +/- 190 ml
  • tap at the bottom allows emptying the bag

Packaging & Labelling

30 baseplates + 30 bags in one package

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