Professional Assisted Feeding & Enteral Delivery Systems
Designed for controlled oral/enteral administration of liquid nutrition, hydration, and clinical supplements in hospital environments.
Product Overview
These Hospital-Grade Human Force Feeding Solutions consist of oral/enteral feeding syringes and accessories intended for the precise delivery of liquids in patients who are unable to self-feed. Built from medical-grade, latex-free materials, they are suitable for acute care, ICU, med-surg, geriatrics, and long-term care units.
For use by licensed healthcare professionals or under medical supervision only.
FDA Regulatory Classification
Oral/enteral feeding syringes with enteral specific connectors are regulated under FDA Regulation Number 876.5980 with the product code PNR. These devices typically fall under Class II (Special Controls) and require a 510(k) premarket notification demonstrating substantial equivalence to predicate devices before marketing in the U.S.
Key regulatory notes:
- FDA classifies most enteral and oral feeding syringes under Class II due to their clinical use in delivering fluids into the gastrointestinal tract.
- ISO 80369-3 standards apply to small-bore connectors and enteral device safety; these syringes often incorporate ENFit-compatible features to reduce misconnections.
- Always verify that each SKU includes proper 510(k) documentation or exemption status before sale.
Clinical Benefits
✔ Precise volumetric delivery for liquid nutrition and supplements
✔ Smooth, low-friction plunger control
✔ Clear, high-contrast graduated markings
✔ ENFit or enteral-specific connectors to support system safety
✔ Latex-free, DEHP-free construction
✔ Single-use sterile and reusable configurations
Product Line
Enteral / Oral Feeding Syringes
- Capacities: 1 ml, 3 ml, 6 ml, 10 ml, 20 ml, 35 ml, 60 ml
- Oral tip and catheter tip variants
- ENFit connector compatibility (when applicable)
Accessories
- Protective caps and hygiene seals
- Connector adapters
- Cleaning accessories (for reusable systems)
Intended Hospital Use
✔ Assisted oral/enteral feeding
✔ Supplement delivery in patients with feeding challenges
✔ Clinical hydration and formula administration
✔ Use in ICU, Med-Surg, Rehab, and Long-Term Care units
⚠️ Not intended for parenteral injection use. Use only in accordance with facility and physician protocols.
Safety & Compliance
- Medical-grade, biocompatible materials
- Designed to comply with infection control and safety standards
- Supports institutional risk management procedures
- Clear labeling and lot traceability for recall readiness
Force feeding carries medical risks if performed incorrectly. Products must be used only by trained professionals following hospital protocols.
Specifications
AttributeDescriptionMaterialMedical-grade polypropylene, latex-freeSterilitySterile single-use and non-sterile reusable optionsCapacity1 ml – 60 mlMarkingsGraduated, high-contrastConnectorsENFit (when specified)ComplianceMeets applicable FDA, ISO small-bore standards
Packaging & Distribution
- Individually sterile packed units
- Hospital bulk boxes (60–200 units)
- Custom labeling available (with compliance review)
- Lot traceability and documentation included