ENFit connector compliant with ISO 80369 3 for small Bore enteral connectors.
Class IIa medical device under MDD 93/42/EEC, Annex V & VII (as stated in technical data sheet).
CE marked with Declaration of Conformity covering LHE25LD (2.5 ml Oral/Enteral Syringe – ENFit Low Dose reusable, non Sterile).
ENFit connector compliant with ISO 80369 3 for small Bore enteral connectors.
Class IIa medical device under MDD 93/42/EEC, Annex V & VII (as stated in technical data sheet).
CE marked with Declaration of Conformity covering LHE25LD (2.5 ml Oral/Enteral Syringe – ENFit Low Dose reusable, non Sterile).
Manufactured by Medicina Ltd under documented quality and performance specifications including leakage, capacity tolerance and sliding performance tests.
Free from latex, phthalates, animal Derived substances, bisphenol A, asbestos and PCBs as per technical data sheet.
Description
2.5 ml ENFit reusable low dose enteral syringe (LHE25LD) designed for safe delivery of enteral feeds, medicines and flushes to neonatal, paediatric and adult patients at home. The syringe is purple to differentiate enteral from other routes, uses an ENFit connector compliant with ISO 80369-3, and features a three-piece design (polypropylene barrel, plunger and silicone rubber piston with O-ring) with clear graduations. Supplied non-sterile for home enteral use in a box of 100 individually packaged syringes.
Bnefits
Provides accurate low dose delivery of enteral medicines and feeds in 2.5 ml capacity with specialised low dose tip design.
ENFit connector in line with ISO 80369-3 helps prevent misconnections with intravenous and other non-enteral systems.
Reusable and washable design for repeated use on the same patient in the home environment, improving convenience and reducing waste.
Purple colour and clear measurement markings support easy identification as an enteral-only device and accurate dose measurement.
Three-piece construction with silicone gasket and O-ring provides smooth plunger movement and helps prevent swelling during cleaning.
Manufactured from polypropylene and silicone rubber, free from latex, phthalates and DEHP, reducing risk of sensitivities.
Individually packaged syringes in a box of 100 support hygienic storage and handling.
Class IIa CE-marked medical device with documented technical performance and quality controls.
Indications
Measurement and administration of liquid enteral feeds via ENFit feeding tubes in neonatal, paediatric and adult patients at home.
Measurement and administration of liquid enteral medicines through ENFit-compatible enteral feeding systems.
Flushing of enteral feeding tubes and lines using water or appropriate flush solutions via ENFit connection.
Aspirating small volumes of enteral fluid from feeding systems where appropriate, in line with clinical guidance.
Manufactured by Medicina Ltd under documented quality and performance specifications including leakage, capacity tolerance and sliding performance tests.
Free from latex, phthalates, animal Derived substances, bisphenol A, asbestos and PCBs as per technical data sheet.
Distributed in the UK by Medisave UK Ltd, an MHRA Registered wholesaler operating ISO 9001 and ISO 14001 management systems.
Distributed in the UK by Medisave UK Ltd, an MHRA Registered wholesaler operating ISO 9001 and ISO 14001 management systems.
ENFit reusable low dose enteral syringes
Barrel, plunger and tip: Polypropylene.
Piston (gasket): Silicone rubber (latex-free).
Lubricant: Silicone oil.
Free from latex, phthalates, animal-derived substances, bisphenol A, asbestos and PCBs.
Non-sterile ENFit home syringe (LHE series) with purple colouring for enteral use.
Formulation
2.5 ml ENFit reusable low dose oral/enteral syringe, non-sterile, three-piece polypropylene barrel and plunger with silicone rubber piston and O-ring, purple, ISO 80369-3 compliant ENFit connector.
Packaging
Box of 100 ENFit reusable 2.5 ml low dose enteral syringes (LHE25LD).
Each syringe supplied individually packaged (single blister or bag as per technical sheet).
Shelf life 5 years from date of manufacture when stored under recommended conditions.
Usage
Use only for oral/enteral administration via ENFit-compatible feeding tubes or enteral accessories; do not use for intravenous or other parenteral routes.
Before first use and between uses, wash the reusable syringe according to local protocols (e.g. warm water and suitable detergent), ensuring all residues are removed from barrel, tip and piston.
Allow the syringe to dry fully after cleaning; the O-ring on the silicone gasket is designed to help prevent swelling during cleaning.
Draw up the prescribed volume of enteral feed, flush solution or medicine using the clear 2.5 ml graduations to ensure accurate dosing.
Connect the ENFit tip securely to the matching ENFit feeding tube or extension set before administering the feed, flush or medicine.
After each use, disconnect, flush and clean the syringe promptly, inspecting for damage, stiffness of plunger or fading of markings; discard and replace the syringe if any defect is observed.
Use the syringe only on a single patient and follow local home enteral feeding guidance for maximum reuse period and cleaning method.
Dispose of used syringes in accordance with local regulations for medical/home healthcare waste when they reach the end of their usable life or at the expiry date.
Contraindications
Do not use for intravenous, intramuscular, subcutaneous or any parenteral administration routes.
Not suitable for use with luer or other non-ENFit connectors; ENFit syringes are specifically designed for enteral systems.
Do not use if packaging is damaged, syringe components show visible defects, or graduations are illegible.
Patients or carers unable to follow cleaning and reuse instructions safely should not use reusable syringes without appropriate support or alternatives.
Adverse Effects
No specific adverse effects are listed by the manufacturer for this device; risks are primarily related to incorrect route of administration or misconnection, which ENFit design aims to reduce.
Potential general device-related issues may include leakage, plunger stiffness or failure, or inaccurate dosing if the syringe is worn or damaged; syringes should be inspected regularly and replaced as needed.
Improper cleaning or reuse against local guidance may increase the risk of contamination or infection.
Storage Conditions
Store in original packaging in a clean, dry environment.
Recommended storage temperature between 5°C and 35°C with maximum relative humidity of 80%.
Protect from direct sunlight, excessive heat, moisture and mechanical damage to packaging.
Do not use beyond the labelled expiry date (5-year shelf life from date of manufacture).
Duration
Reusable non-sterile home enteral syringe intended for repeated use on a single patient over its 5-year shelf life, with actual in-use duration and replacement frequency determined by local clinical and home enteral feeding protocols.
Onset
Immediate effect in terms of delivery of enteral feed, flush or medicine once the syringe contents are administered through a correctly placed enteral feeding tube.
