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

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

Valid Article

Former Code(s): -X
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

Paediatric sterile adhesive bag for urine collection.

Technical specifications

  • pouch = transparant plastic (PVC, PE, ..) for permanent visual control of urine.
  • surface adhesive with zinc oxide (latex free)
  • ​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, for single use

Packaging & Labelling

Packed in individual peelable blisters (1 peelable paper side with legal information, 1 transparent side) and are sold in boxes of either 20, 50 or 100 units.

Instructions for use

  • Wash your hands very carefully.
  • Place the child on its back.
  • Carefully clean the skin with water and neutral soap. Antiseptic can be used on medical prescription only. The skin should be clean, dry, left ungreased and unpowdered. The skin must be free from irritation.
  • Remove and discard central panel of the adhesive.
  • Carefully and gently remove the release paper of the adhesive.
  • Apply the pouch around the baby's penis or vulva with gentle pressure to ensure all edges are well sealed.
  • To remove, gently lift one corner and peel off.
  • To protect specimen, seal edges immediately upon removal, and if necessary add further strip of adhesive tape.
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Precautions for Use

Make sure that the size of the pouch is adapted to the weight of the child

Within the context of biochemical, cytological and bacteriological examinations, the pouch should not be applied for more than 30 minutes avoiding by this way any risk of urine contamination (false positive). Even if the pouch is empty, you should replace it.

Send the urine to the analysis laboratory within 2 hours of collection. If this is impossible the specimen may be kept in a fridge for a maximum of 12 hours. Indicate the collection time on pouch.

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Publication of this NST technical sheet validated by NCWG Febr 2023