General information
For gastro-enteral feeding using Luer-tip syringes.
For ventricular lavage.
Specifications
A thin, flexible and hollow sterile cylinder used to access a patient’s stomach through the nose and nasopharynx; used primarily for enteral feeding and administering medication.
Synonym: Nasogastric feeding tube.
Materials:
Polyvinyl chloride (PVC), medical grade.
Description:
- Single channel tube.
- Radio-opaque line for continuous X-ray.
- Marked 20cm from the distal end.
- Round and smooth-ended tip.
- Two opposite ovals, displaced side holes or eyelet.
- Connector with a Luer tip and stopper.
- Length: for size CH06 and CH08 is 40-50cm; for CH10 50-60cm.
Unit presentation:
1 feeding tube, sterile, single-use, peel pack.
Primary packaging:
Must be supplied in a sterile peel or blister pack. Labelling should mention: Manufacturer’s name and/or trademark. "sterile", lot number, expiry date by year and month, "for single use", CE mark and reference number for notifying body, product description, and instructions for use. Must be multilingual: English, French and Spanish, others when available.
Secondary packaging:
Protected unit, one (1) box with 50- or 100-unit presentation, labelling to is the same as that of primary packaging.
Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).
Other requirements:
Norms: Must comply with:
- Medical Device Directive 93/42/EEC, risk class IIa
- EN 1615: Enteral feeding catheters and enteral giving sets for single use and their connectors - Design and testing
- EN 550 Sterilization of Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization.
NOTE:
- Use syringe MINSSYRD100 SYRINGE, 100ml, 3 parts, with catheter and a Luer nose.
- For sizes higher than CH10, use gastric tube MCTDTGAS.