ENFit and ISO 80369-3 What Buyers Need to Check
ENFit syringes follow ISO 80369-3 across 7 sizes from 1ml to 100ml. Class II sterile devices with CE, ISO and US FDA K number.
The ISO 80369-3 Standard for Enteral Connections
Nineluck enteral syringes use the dedicated ENFit tip connector manufactured to the ISO 80369-3 standard for enteral feeding. This standard specifies connector geometry to prevent misconnections between enteral lines and other clinical delivery systems. The syringes are supplied as Class II sterile devices backed by CE, ISO and US FDA K-number clearances.
Syringe Sizes and Universal Cap Design
The ENFit syringe line covers seven capacities: 1ml, 3ml, 5ml, 10ml, 20ml, 60ml and 100ml. Every size is available either with or without a protective cap. To simplify inventory management across clinical departments, one specially designed ENFit cap fits all seven barrel capacities.
Packaging Formats and Packaging Configurations
Units are supplied sterile for single-use applications in either blister packing or poly bag packaging. Importers and hospital tender contractors can specify packaging according to local sterilization barrier standards, central sterile services department preferences or private-label cartoning requirements.
Related Devices in the Enteral Delivery System
Beyond individual syringes, the ENFit portfolio covers complete administration hardware. The range includes enteral gravity sets, dedicated feeding bags, extension sets and loose components designed to mate with standard enteral access tubes.
What to Confirm Before Ordering
Confirm your required syringe capacities, whether units should ship capped or uncapped, and your choice between poly bag or blister packaging. Specify whether your order requires OEM branding or standard Nineluck labelling, and confirm regulatory documentation requirements for your port of import.
Products Covered In This Guide
Enteral Syringe with ENFit CapENFit Enteral Syringe, With or Without CapView specifications
Enteral Set and Bag with ENFit ConnectorENFit Enteral Gravity SetView specifications
Enteral Set and Bag with ENFit ConnectorENFit Extension SetView specifications
Enteral Set and Bag with ENFit ConnectorENFit Enteral ComponentsView specificationsQuestions On This Topic
Which connector standard do these enteral syringes follow?
They use ENFit tip connectors built according to the enteral application standard ISO 80369-3.
What barrel capacities are available?
Available sizes are 1ml, 3ml, 5ml, 10ml, 20ml, 60ml and 100ml.
Do different syringe volumes require different cap sizes?
No. One specially designed cap fits all sizes from 1ml to 100ml.
What regulatory clearances exist for these syringes?
They are Class II sterile devices with CE, ISO and US FDA K-number clearances.
What sterile packaging formats can be selected?
Units can be ordered in either individual blister packaging or poly bags.
Are complementary ENFit administration products available?
Yes. The range includes gravity sets, feeding bags, extension sets and loose components.
Ask About These Products
Send the sizes and quantities you are considering and the quotation comes back with the certificate copies for those catalogue numbers.