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URINE COLLECTION BAG, CHILD, closed, adhesive, sterile, boy

https://unicat.msf.org/cat/product/27888
NST SCTDBAGU3PB

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).
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.
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
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, pediatric, adhesive, closed ended

Definition

A sterile, flexible plastic pouch with an adhesive flange (typically with a gender-specific shape) intended to be attached to the skin around the genitalia to collect urine from an infant/paediatric patient. It is not designed with an opening for urine drainage and is typically used for biochemical, cytological and/or bacteriological sampling. This is a single-use device.

Specifications

Technical specifications

  • pouch = transparant plastic (PVC, PE, ..) for permanent visual control of urine.
  • surface adhesive with zinc oxide
  • ​adhesive flange with a gender-specific shape
  • ​closed bag: is not designed with an opening for urine drainage
  • content: 100 ml
  • suitable for children > 2.5 kg
  • sterile, single use

Instructions for use

Skin preparation: dry, free of oily components.

MSF requirements

“These bags are notorious for not sticking and even collecting a sample can be difficult, therefore the use for monitoring urine output should not be encouraged.

Often there is an access point to collect the sample on the closed system so it is not necessary to pour the urine to collect the sample. The closed system preferred as it is more likely to stay in place and is less irritable than the bag with the drainage system.”

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Publication of this NST technical sheet validated by NCWG Febr 2023