TUBE, GASTRIC, dble chann. (Salem) conical, 125 cm s.u. CH16

STD SCTDTUGS16-

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).
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.
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)

GASTRIC TUBE, double channel (Salem)

Definition

A sterile, thin, flexible, hollow, double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx.

Salem-sump: is a two-lumen nasogastric/orogastric tube. The dual lumen tube allows for safer continuous and intermittent gastric suctioning.

  • The large lumen allows for easy suction of gastric contents, decompression, irrigation and medication delivery.
  • The smaller vent lumen allows for atmospheric air to be drawn into the tube and equalizes the vacuum pressure in the stomach once the contents have been emptied. This prevents the suction eyelets from adhering to and damaging the stomach lining.

Synonym

Salem tube, nasogastric sump tube, gastrointestinal decompression tube.

Specifications

The tube contains two lumens. The larger of the two lumens is oval in shape. The smaller lumen has a single distal opening that shares a common intratube space with the larger lumen. The distal end of the tube contains a total of +/- 10 drainage holes within a tube length of 5-10 cm.

When suction is applied to the larger lumen, gastric fluid is removed, the stomach lumen is reduced, and gastric mucosa may block the opening of the drainage holes. The resulting increase in negative pressure within the tube causes air to enter the air vent and travel in a downward direction to the tip of the tube, and then upward through the aspirating lumen. This air vent/sump mechanism facilitates collection of gastric fluid and limits excess negative pressure that might cause suction damage to gastric mucosa.

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Quality standards

ISO 20695, 2020, Enteral feeding systems — Design and testing

Technical specifications

  • Transparent PVC
  • Double channel:
    • main channel with funnel shape connector for suction
    • secondary channel with funnel shape connector for irrigation and venting
  • Closed distal end, with minimum 9 lateral eyes with atraumatic edges
  • Radio-opaque markings for easy positioning
  • Sterile, for single use
  • Dimensions:
    • External diameter: CH10, CH12, CH16, CH18 and CH20
    • Length: 90 to 125 cm

Packaging & Labelling

Unit sterile packaging in peel-open pack

(Cf Introduction: Packaging and labelling)

To be Ordered Separately

The biconical connector for connecting the tube to the suction system should be ordered separately (see related articles below).

Instructions for use

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Precautions for Use

Confirm the correct position of nasogastric tubes

See information on Nasogastric and enteral tubes.

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