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ENTERAL FEEDING RESERVOIR, top fill, >=1000 ml, + cap

https://unicat.msf.org/cat/product/80182
STD SCTDENFB02-

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).
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.
A080101 - Enteral feeding bags and containers (including those via pump), single-use
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
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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ENTERAL FEEDING RESERVOIR

Definition

An empty pouch or bottle made of plastic intended to contain a fluid of nutrients for administration to a patient through an enteral tube that provides direct access to the stomach, duodenum, or jejunum. It is provided with a short length of tubing but is not intended to be directly connected to the feeding tube. This is a single-use device.

Specifications

Technical specifications

  • Material : plastic transparent / translucent
  • Easy to read graduations
  • ENPlus connection to be connected to an administration set for enteral nutrition
  • Large top fill opening with attached cap and hook or other means to attach the pouch to a pole.
  • Volume: 500 ml or 1000 – 1600 ml
  • Non sterile
  • For single patient use

To be Ordered Separately

The administration set that connects the feeding bag with the nasogastric tube has to be ordered separately. see related articles.

Instructions for use

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Precautions for Use

Single patient use. To avoid product contamination problems, the system (bag and administration set) should be replaced at least every 24 hours, or as needed.

  • Therapeutic milk F75 must be used within 2 hours.
  • ORS / Resomal should be used within 24 hours.

MSF requirements

The top-fill enteral nutrition bag allows the administration by gravity of non-ready to use solutions for enteral feeding (Therapeutic milk) or for enteral hydration (ORS or Resomal) if a close control of flow rate is required (critically ill malnourished patients) or when the volume to administer is too big to use 60 ml enteral syringe.

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