ENFit Enteral Syringe, With or Without Cap
A single-use sterile enteral feeding syringe featuring an ENFit tip connector manufactured to the ISO 80369-3 standard.
What This Product Is
A single-use sterile enteral feeding syringe featuring an ENFit tip connector manufactured to the ISO 80369-3 standard. Available in capacities from 1ml to 100ml, it is configured with or without a protective cap and is supplied in poly bag or blister packaging. The device holds CE, ISO, and US FDA 510(k) clearance as a Class II sterile medical device.
- Connector standard: ISO 80369-3 (ENFit)
- Available sizes: 1ml, 3ml, 5ml, 10ml, 20ml, 60ml, 100ml
- Cap configuration: With cap or without cap
- Cap compatibility: Universal fit across all sizes
Why Buyers Pick This Reference
- ENFit tip connector complies with ISO 80369-3 to reduce tubing misconnection risks during clinical enteral feeding procedures
- Available in seven standard volume capacities ranging from 1ml up to 100ml for precise enteral nutrition delivery
- Offered with or without a specially designed universal cap that securely fits every syringe size in the range
- Certified as a Class II sterile device backed by CE, ISO, and US FDA 510(k) regulatory clearances
- Flexible packaging options provide either individual poly bag or individual blister packing according to hospital and distributor procurement needs
The Product As It Ships
How It Is Built
- Dedicated ENFit connector tip manufactured in strict accordance with the enteral application standard ISO 80369-3
- Full volume selection covering 1ml, 3ml, 5ml, 10ml, 20ml, 60ml, and 100ml barrel capacities
- Specially engineered cap design engineered to fit universally across every syringe size in the entire line
- Class II sterile single-use medical device verified under CE, ISO, and US FDA 510(k) regulatory clearance
- Packaging choices include sterile poly bag packing or rigid blister packaging to suit diverse clinical storage requirements
Sizes Packing and Materials
Only values printed on the original product documentation are listed. Anything still marked TBC is confirmed per order rather than guessed here.
| Connector standard | ISO 80369-3 (ENFit) |
|---|---|
| Available sizes | 1ml, 3ml, 5ml, 10ml, 20ml, 60ml, 100ml |
| Cap configuration | With cap or without cap |
| Cap compatibility | Universal fit across all sizes |
| Regulatory status | CE, ISO, US FDA K-number Class II sterile device |
| Packaging options | Poly bag package or blister package |
| MOQ | TBC |
| Lead time | TBC |
- Moulded enteral syringe barrel, plunger, and connector built to ISO 80369-3 dimensional specifications
- Dedicated protective cap material engineered to fit securely across all seven syringe barrel sizes
Buyers This Product Was Built For
- Medical device distributors sourcing enteral nutrition lines compliant with current ISO 80369-3 connection standards
- Hospital tender agents seeking Class II sterile enteral syringes with valid CE mark and US FDA 510(k) registration
- Private-label brand owners requiring OEM artwork, custom packaging formats, and flexible cap configurations
- Home-care consumables importers needing single-use feeding syringes supplied in blister or poly bag packaging
What Goes Wrong Without It
- Legacy non-luer and luer connectors risk dangerous misconnection to IV lines, solved by ISO 80369-3 ENFit geometry
- Procuring multiple sizes from different vendors complicates documentation, solved by offering 1ml through 100ml from one source
- Syringes lacking sterile regulatory documentation fail customs clearance, solved by complete CE, ISO, and US FDA Class II files
- Different cap fittings across various volume sizes complicate ward inventory, solved by a universal cap fitting all sizes
Where It Is Used
Enteral medication and formula administration in neonatal, paediatric, and adult hospital wards using ISO 80369-3 feeding systems
Clinical nutrition delivery protocols requiring Class II sterile syringes with verified US FDA 510(k) regulatory clearance
Home-care enteral feeding applications where syringes must be capped between preparation and final administration
Tender bids requiring complete size ranges from 1ml through 100ml with standardised ENFit enteral connectors
How It Is Made
- Components are moulded to meet precise ISO 80369-3 ENFit enteral connector dimensions
- Syringe barrels and plungers are assembled and fitted with or without the universal protective cap
- Devices are sealed into individual poly bags or blister packaging according to order specifications
- Products undergo sterilisation processing to deliver Class II sterile finished devices
What Is Checked Before It Ships
- ENFit connector dimensions verified against the ISO 80369-3 enteral standard requirements
- Cap fit security inspected to confirm reliable placement across all syringe volume sizes
- Packaging seal integrity inspected across both blister and poly bag production lines
- Manufacturing sites hold verified CE, ISO, and US FDA Class II compliance records
What Can Be Changed For Your Brand
- Choice between sterile blister packaging and sterile poly bag packaging formats
- Supply configuration available with the universal ENFit cap or without cap
- OEM and ODM sample design adaptation including custom artwork and catalogue numbering
- Selection of individual sizes or the complete 1ml to 100ml range per order
How It Compares With The Alternatives
| Standard Luer Syringe | Standard luer syringes allow cross-connection with intravenous lines, whereas ISO 80369-3 ENFit connectors prevent accidental misconnection. |
|---|---|
| Syringe with Size-Specific Caps | Size-specific caps require multiple inventory items, whereas this universal cap design fits all volumes from 1ml to 100ml. |
How It Is Used
- Verify package integrity, syringe volume capacity, and expiration date prior to opening the sterile barrier
- Peel open the blister or poly bag using standard aseptic hospital technique
- Remove the protective universal ENFit cap if the syringe is supplied in a capped configuration
- Connect the ISO 80369-3 ENFit tip directly to the matching enteral feeding tube or administration port
- Administer prescribed nutrition or medication and dispose of the single-use syringe in accordance with facility protocols
ENFit Enteral Syringe, With or Without Cap Buyer Questions
What sizes are available for the ENFit enteral syringe?
The syringe is available in 1ml, 3ml, 5ml, 10ml, 20ml, 60ml, and 100ml volumes, supplied either with or without a cap.
Which connector standard does this syringe follow?
The connector conforms to ISO 80369-3, the international standard for enteral feeding applications.
What regulatory certifications and clearances are available?
The syringes are Class II sterile devices backed by CE, ISO, and US FDA K-number clearances.
What packaging options can we order?
You can specify individual poly bag packaging or individual blister packaging depending on your market and clinical requirements.
Does the cap fit every syringe size?
Yes, the specially designed ENFit cap fits all syringe capacities from 1ml up to 100ml.
What is the minimum order quantity?
MOQ is TBC. Please share your required volume sizes and packaging formats to confirm order minimums.
What is your standard production lead time?
Lead time is TBC. It depends on order volume, packaging choice, and whether OEM custom artwork is required.
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Send the size, the variant and the quantity. The reply carries pricing, packing and the CE, FDA and ISO certificate copies for this catalogue number.