ENFit Enteral Components
A range of dedicated enteral feeding components including purple stepped connectors with tubing, clear plastic connectors with purple threaded caps, and enteral syringes.
What This Product Is
A range of dedicated enteral feeding components including purple stepped connectors with tubing, clear plastic connectors with purple threaded caps, and enteral syringes. Designed around the ISO 80369-3 standard to eliminate misconnections between enteral nutrition lines and intravenous or other non-enteral medical fluid lines. Supplied through manufacturers approved by CE, ISO and US FDA to support enteral feeding lines, bags and clinical dispensing kits.
- Device Class: US FDA K-number Class II sterile devices
- Approvals: CE, FDA, ISO
- Components: Stepped connectors, clear plastic connectors, threaded caps, tubing, enteral syringes
- Colour coding: Purple
Why Buyers Pick This Reference
- Follows the ISO 80369-3 standard to physically prevent accidental cross-connection with intravenous Luer lines
- Purple coloration immediately distinguishes enteral feeding pathways from vascular access devices and urinary lines
- Threaded purple caps and stepped connectors maintain closed enteral delivery lines during nutrition administration
- Supplied via manufacturing partners holding CE, ISO and US FDA Class II 510k regulatory approvals
- Supports OEM kit assembly for enteral feeding sets, nutrition bags and clinical syringe dispensing systems
The Product As It Ships
How It Is Built
- Connectors and syringe tips conform strictly to the international enteral connector standard ISO 80369-3
- Distinct purple color coding across connectors, caps and syringe bodies for instant line identification
- Threaded locking caps seal connector ports securely against leaks and outside fluid pathway contamination
- Stepped connector profile joins securely to matching enteral delivery tubing for reliable fluid administration
- Supplied as Class II sterile devices backed by US FDA K-number, CE and ISO approvals
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.
| Device Class | US FDA K-number Class II sterile devices |
|---|---|
| Approvals | CE, FDA, ISO |
| Components | Stepped connectors, clear plastic connectors, threaded caps, tubing, enteral syringes |
| Colour coding | Purple |
| Customization | OEM and ODM customer sample design accepted |
| MOQ | TBC |
| Lead time | TBC |
- Moulded medical plastic engineered for clear connector bodies and purple-tinted enteral identification parts
- Flexible tubing assembled to stepped purple plastic connectors to integrate directly into feeding lines
Buyers This Product Was Built For
- Enteral nutrition set manufacturers looking for compliant ISO 80369-3 connectors, syringes and caps
- Medical device distributors supplying nutrition bags and gravity administration sets to hospital accounts
- Private-label brands requiring custom sample design and OEM packaging for enteral feeding accessories
- Tender agents sourcing certified CE, ISO and FDA Class II enteral feeding line components
What Goes Wrong Without It
- Non-dedicated connectors risk catastrophic line crossover between enteral nutrition feeds and intravenous vascular lines
- Legacy enteral connections come uncoupled under pressure without a secure locking threaded interface mechanism
- Procurement teams struggle to obtain full CE, FDA and ISO regulatory files for small connector subcomponents
- Brand owners cannot find a single partner to supply matching purple syringes, caps, connectors and tubing
Where It Is Used
Enteral nutrition administration via feeding bags and dedicated infusion set assemblies in hospitals
Medication and fluid dispensing using dedicated purple ISO 80369-3 enteral syringes in inpatient wards
Connecting enteral feeding tubes to nutrition delivery bags in clinical and home-care settings
Transitioning legacy enteral tube feeding hardware over to standard ISO 80369-3 ENFit locking connections
How It Is Made
- Connector bodies, threaded caps and syringe components are injection moulded to ISO 80369-3 engineering dimensions
- Tubing sections are joined to stepped purple connector barbs and inspected for joint retention
- Subcomponents and syringes undergo cleanroom assembly, packaging and sterilization as Class II medical devices
- Packed into shipper cartons carrying client catalogue references, artwork and customs shipping marks
What Is Checked Before It Ships
- Dimensional verification confirms all connection interfaces mate accurately to standard ISO 80369-3 enteral fittings
- Fluid pathway integrity and seal security verified across threaded purple caps and line connector junctions
- Production lots manufactured under certified ISO, CE and US FDA quality management system guidelines
What Can Be Changed For Your Brand
- OEM and ODM production following customer sample designs for specialized enteral nutrition line components
- Custom packaging formats including bulk component packaging or pre-packaged individual sterile device pouches
- Private-label packaging, custom outer carton printing, buyer catalogue numbers and specific shipping marks
How It Compares With The Alternatives
| Standard Luer connectors | Luer connectors carry high risks of accidental connection to IV lines, whereas ISO 80369-3 ENFit geometry physically prevents mating with non-enteral devices |
|---|---|
| Non-threaded friction fit enteral connectors | Friction taper connectors can pull loose during patient movement, while threaded ENFit locking caps and connectors provide a rigid mechanical seal |
How It Is Used
- Inspect the sterile pouch and verify connector and syringe compatibility with ISO 80369-3 enteral ports
- Remove protective packaging or purple caps using aseptic handling before mating to the enteral tube line
- Thread the connector firmly into the matching enteral line port until the locking mechanism is seated
- Attach protective purple threaded caps whenever the enteral connector line is temporarily disconnected
- Dispose of single-use enteral syringes, connectors and caps in accordance with standard clinical waste protocols
ENFit Enteral Components Buyer Questions
What standard do these enteral connectors and syringes comply with?
All ENFit enteral components and syringes follow the international enteral connector standard ISO 80369-3.
What regulatory certifications cover these enteral components?
The manufacturing sites Nineluck invests in hold CE, ISO and US FDA Class II 510(k) sterile device clearances.
Can you produce custom enteral components based on our technical drawings or samples?
Yes. We accept customer sample design and provide OEM and ODM manufacturing services to match your specifications.
Are the connectors and syringes color coded for enteral use?
Yes. The connectors, caps and enteral syringes utilize purple identification colouring to distinguish them from IV access lines.
What is the lead time for enteral component orders?
TBC. Lead times depend on component selection, order volume and OEM packaging requirements, which we confirm upon inquiry.
What is the minimum order quantity?
TBC. Share your required component catalogue numbers, sizes and quantities, and we will advise the minimum order requirement.
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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.