ENFit Enteral Feeding Syringe 30ml
The ENFit Enteral Feeding Syringe 30ml is an enteral delivery device manufactured in accordance with the ISO 80369-3 standard to eliminate misconnection risks with vascular lines. Featuring a nominal volume of 30ml and a precise female ENFit connector, this device supports clinical tube feeding, bolus enteral nutrition, and oral liquid medication administration in healthcare facilities. Complete technical documentation, compliance data, and direct factory quotation support are available for medical equipment distributors, importers, and procurement personnel.
Key Features
ISO 80369-3 Connector Standard: Fits standard enteral feeding tubes and transition adapters, preventing accidental misconnections with vascular lines.
DEHP-Free & Latex-Free Construction: Molded entirely from medical-grade polypropylene and synthetic rubber to eliminate chemical leaching risks during fluid transfer.
High-Contrast Graduation Marks: Printed with dark, solvent-resistant medical ink to guarantee clear volume readability during rapid clinical preparation.
Controlled Plunger Movement: Precision synthetic rubber gasket minimizes sliding friction, enabling smooth, uniform pushing force during manual operation.
Purple Barrel Identification: Color-coded plunger and barrel components provide immediate visual identification for enteral applications.
Dual-Gasket Seal Integrity: Engineered stopper rings retain complete liquid containment under manual injection pressure.
Technical Specifications
|
Parameter |
Specification |
|
Capacity |
30 ml |
|
Graduation |
1.0 ml increments |
|
Connector |
ISO 80369-3 ENFit Female |
|
Barrel / Plunger Material |
Virgin Medical-Grade Polypropylene (PP) |
|
Gasket Material |
Synthetic Isoprene Rubber (Latex-Free, DEHP-Free) |
|
Sterilization |
Ethylene Oxide (EO) |
|
Sterility Level |
SAL 10-6 |
|
Shelf Life |
5 Years |
|
Cleanroom Standard |
Class 100,000 (ISO Class 8) |
Design and Construction
Locking Interface: Dedicated connection profile secures tightly with compatible feeding lines, preventing accidental detachment during fluid delivery.
High-Clarity Barrel: Transparent polypropylene wall allows clear visual monitoring of liquid volume, dosage accuracy, and fluid turbidities.
Ergonomic Flange Design: Widened finger flanges provide mechanical leverage and stability during single-handed clinical operation.
Retention Notch: Internal stop ring prevents accidental plunger displacement during fluid aspiration.
Intended Use and Applications
Enteral Nutrition Administration
Delivers liquid nutritional formulas through nasogastric, gastrostomy, or jejunostomy feeding tubes.
Medication Delivery
Administers liquid medications and dissolved treatments through dedicated enteral access lines.
Feeding Line Flushing
Clears feeding tube blockages using sterile water or flushing solutions.
Quality and Regulatory Information
Quality System Management: Manufactured under ISO 13485 quality management system requirements for medical devices.
Dimensional Conformance: Fully compliant with ISO 80369-3 dimensions and ISO 7886 standards for single-use sterile syringes.
Sterilization Validation: Ethylene oxide process validated according to ISO 11135, maintaining residual limits within regulatory standards.
Full Batch Traceability: Individual blister packaging and outer cartons feature lot numbers tied directly to raw material and sterilization records.
Packaging and Supply
|
Sterile Single Pack |
Individual peelable blister package composed of medical-grade paper and film. |
|
Bulk Packaging Options |
Non-sterile cleanroom bulk packaging options available for kit integration. |
|
Corrugated Shipping Boxes |
5-layer export boxes structured to withstand long-distance transit stresses. |
|
Palletized Transport |
Optional palletizing with shrink wrap and edge protection boards for bulk freight protection. |
Customization Options
Color Tinting: Customized plunger or barrel component color variations according to institutional specifications.
Scale Marking Modifications: Custom graduation layouts, dual-scale markings, or customized measurement indicators.
Private Packaging: Custom printing on blister packaging, unit boxes, and outer shipping cartons.
Procedural Kitting: Custom packaging sizes structured for integration into specialized clinical feeding trays.
FAQ
Q: Does this syringe connect to standard Luer ports?
A: No. This syringe uses an ISO 80369-3 ENFit connector intended solely for enteral lines to prevent accidental misconnection with vascular access points.
Q: Are evaluation samples available for fit testing?
A: Sterile factory samples can be provided to verify dimensional fit with target enteral tubes prior to commercial order placement.
Q: What materials are used to ensure chemical safety?
A: The barrel and plunger are molded from virgin medical-grade polypropylene, paired with a synthetic rubber gasket free of natural latex and phthalates.
Q: What documentation accompanies completed orders?
A: Every production batch includes a Certificate of Analysis alongside an Ethylene Oxide Sterilization Certificate.
Q: Are the graduation markings resistant to wiping or exposure?
A: Yes. The printing ink undergoes solvent rub resistance testing to ensure scale lines remain clear and legible during routine clinical handling.
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