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NASOGASTRIC TUBE, ENFit tip, s.u., 50 cm, CH08, blue

https://unicat.msf.org/cat/product/69691
STD SCTDTUGF08-

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.
G02020101 - Nasogastric tubes
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.
IIa
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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NASOGASTRIC TUBE, ENFit tip

Definition

A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump. It is typically a single-lumen plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides.

The NG-tube is designed with a specific ENFit end so that you can only use products designed for enteral/tube feeding access.

Specifications

Quality standards

ISO 80369-3, 2016, edition 1, +A1 2019 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications

Quality Standards Comment

See information on nasogastric and enteral tubes

Technical specifications

  • Transparent
  • PVC or polyurethane
  • Single channel
  • Closed distal end, with minimum 2 oval lateral eyes with atraumatic edges
  • Proximal end with purple ENFit connection + stopper
  • Radio-opaque or with radio-opaque markings for easy positioning (minimum / 5 cm)
  • Possibility of identification of the size once the tube is out of the packaging, by colour code is preferred (coloured ring built into the connector, coloured closure cap, coloured attachement of the closure cap)
  • Sterile, for single use
  • Dimensions:
    • Length: 40 to 60 cm (CH6 - 10) or 90 cm (CH12 & 14)
    • Diameter: CH6, CH8, CH10, CH 12 and CH 14
    • Size indicated by an international colour code:
sizeext diam mmcolour
CH62.0 mmlight green
CH82.7 mmblue
CH103.3 mmblack
CH124.0 mmwhite
CH144.7 mmgreen

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

Instructions for use

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Precautions for Use

  • Confirm the correct position of nasogastric tubes
  • Prevent misconnection errors

See information on nasogastric and enteral tubes

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