The ENFit Enteral Feeding Syringe 5ml is a single-use enteral medication and nutrition administration device equipped with a female ISO 80369-3 compliant ENFit connector. Featuring a 5ml nominal capacity and permanent graduated markings, this syringe provides precise low-volume delivery into enteral feeding tubes while preventing accidental connection to vascular or respiratory lines. Technical specifications, sterile barrier packaging data, and compliance documentation are provided for medical device importers, distributors, and healthcare facility supply managers.

Key Features

ISO 80369-3 ENFit Interface: Standardized female connector design mates exclusively with enteral feeding ports to eliminate clinical misconnection risks.

0.1ml High-Contrast Graduations: Permanent, solvent-resistant scale markings ensure accurate volumetric verification for pediatric and micro-dose administration.

Enteral Purple Designation: Distinct visual color coding instantly separates enteral lines from intravenous or other clinical fluid pathways.

Controlled Plunger Glide: Synthetic rubber gasket paired with micro-sprayed medical silicone maintains consistent, force-free manual push resistance.

Biocompatible Materials: Medical-grade polypropylene barrel and plunger formulations are entirely free of natural rubber latex, DEHP, and BPA.

Sterile Barrier Pouch: Individual peelable medical paper packaging preserves internal sterility up to the moment of clinical deployment.

Technical Specifications

Parameter	Technical Value
Volumetric Capacity	5 ml
Scale Graduation	0.1 ml increments
Dosing Accuracy	± 4% at nominal volume
Connector Standard	ISO 80369-3 (ENFit Female Tip)
Barrel & Plunger Material	Medical-grade Polypropylene (PP)
Gasket Seal Material	Synthetic Isoprene Rubber (Latex-Free)
Internal Lubricant	Medical Silicone Oil (< 0.25 mg/cm²)
Sterilization Method	Ethylene Oxide (EO), SAL 10⁻⁶
Residual EO Limit	≤ 10 μg/g
Shelf Life	5 Years

Design and Construction

The transparent barrel is precision injection-molded from medical-grade polypropylene, allowing immediate visual detection of fluid levels and trapped air bubbles. The female ENFit tip adheres strictly to ISO 80369-3 dimensional tolerances, securing leak-free engagements with feeding tubes and fill straw adapters. Plunger motion is regulated by a low-friction elastomeric gasket that prevents sudden slip-stick movement during micro-volume pushes. Scale ink formulations undergo routine friction testing to resist rubbing, alcohol wipes, and ambient humidity during clinical preparation.

Intended Use and Applications

Pediatric and Neonatal Care: Micro-dose delivery of liquid medications, oral suspensions, and nutritional supplements via enteral access ports.

Inpatient Enteral Nutrition: Administration of prescribed liquid formulas through nasogastric, gastrostomy, or jejunostomy feeding tubes.

Home Healthcare Support: Routine daily administration of liquid nutrition and oral medications for non-ambulatory or dysphagic patients.

Quality and Regulatory Information

Manufacturing operations are maintained under ISO 13485 quality management systems within controlled cleanroom environments. Each production batch undergoes routine testing for connection seal integrity, glide force consistency, particulate cleanliness, and EO sterilization residuals. Full regulatory support packages-including EU MDR compliant CE certificates, declarations of conformity, and ISO 10993 biocompatibility test reports-are available for import registration and customs clearance.

Packaging and Supply

Primary Packaging	1 piece per sterile paper-plastic peel pouch
Inner Dispenser Box	100 pieces per printed box (lot number and expiry indicated)
Master Shipping Carton	1,000 pieces per corrugated outer carton (10 inner boxes)
Carton Markings	Lot number, manufacture date, expiration date, storage symbols
Storage Conditions	Store below 30°C in dry, well-ventilated areas away from direct sunlight

Customization Options

01/

Private Label Printing: Customized artwork layouts for inner dispenser boxes and master corrugated cartons based on client specifications.

02/

Non-Sterile Bulk Supply: Unsterilized bulk packaging configurations available for specialized medical tray assembly and kit integration.

03/

Accessory Integration: Optional ENFit male closure caps or bottle adapters included within primary pouch packaging or supplied separately.

04/

Graduation Layouts: Specific scale lines or dual-unit markings tailored to regional clinical protocols and guidelines.

FAQ

Q: Does the female tip connect securely with standard ENFit medication ports and bottle adapters?

A: Yes. The female ENFit connector conforms strictly to ISO 80369-3 dimensional standards, forming a secure, leak-free seal with standard male ENFit ports, straws, and bottle adapters.

Q: Are the barrel, plunger, and gasket entirely free of latex and DEHP?

A: Yes. All structural components are formulated completely without natural rubber latex, DEHP, or phthalate plasticizers.

Q: What compliance documentation is provided to support customs import clearance?

A: Shipments are supported by ISO 13485 certification, CE documentation under EU MDR, EO sterilization validation reports, and ISO 10993 biocompatibility data.

Q: What is the standard minimum order quantity and production lead time for OEM orders?

A: Standard production runs start at an MOQ of 50,000 pieces, with typical manufacturing completion ranging between 25 and 35 days following packaging artwork confirmation.

Q: Can physical samples be requested for laboratory and clinical evaluation?

A: Yes. Sterile physical samples accompanied by technical data sheets are provided for clinical trials and internal engineering evaluations upon request.

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