500ml Plastic Irrigation Syringe
500ml Plastic Irrigation Syringe provides uniform fluid delivery and aspiration for surgical wound cleansing, urological procedures, and enteral administration. Featuring a high-transparency barrel with clear graduation markings and an ergonomic plunger assembly, this device supports precise volume management during high-volume clinical flushing. Technical documentation, test reports, and volume-based quotation support are available for medical supply distributors and institutional healthcare buyers.
Key Features
Dual-Scale Graduation Barrel: Chemical-resistant graduation lines enable clear visual volume tracking during fluid intake and evacuation.
Medical-Grade Polypropylene Body: High-clarity polymer provides fluid visibility and structural rigidity during rapid fluid aspiration.
Dual-O-Ring Plunger Seal: Synthetic elastomer rings maintain a leak-free seal under manual pressure without fluid bypass.
Ergonomic Ring Plunger and Grip Flange: Flanged handles provide positive leverage for single-handed operational stability.
Universal Catheter Tip Interface: Smooth tapered tip connects securely with standard catheters, feeding tubes, and irrigation tubing.
Sterile Peelable Pouch Packaging: Medical-grade paper-poly packaging maintains sterile barrier integrity until clinical deployment.
Technical Specifications
|
Technical Parameter |
Specification / Performance Value |
Testing / Compliance Standard |
|
Nominal Volume |
500 ml |
ISO 7886-1 |
|
Volumetric Accuracy |
± 1.5% |
ISO 7886-1 |
|
Barrel Material |
Medical-grade Polypropylene (PP) |
USP Class VI |
|
Plunger Material |
High-density Polyethylene (HDPE) / Polypropylene (PP) |
USP Class VI |
|
Seal Element |
Synthetic Elastomer (100% Latex-Free) |
ISO 10993 |
|
Tip Type |
Catheter Tip / Ring Plunger Type |
ISO 80369-6 |
|
Sterilization Method |
Ethylene Oxide (EO) Gas |
ISO 11135 |
|
Sterility Assurance Level |
10⁻⁶ SAL |
ISO 11135 |
|
Endotoxin Limit |
< 0.25 EU/mL |
USP <85> |
|
EO Residuals |
≤ 10 μg/g |
ISO 10993-7 |
|
Shelf Life |
5 Years |
Real-time & Accelerated Aging |
Design and Construction
Barrel Structural Integrity: High-precision injection molding maintains uniform wall thickness (± 0.05 mm tolerance) to prevent wall collapse under suction pressure.
Low-Friction Plunger Glide: Automated micro-dosing of medical silicone lubricant ensures smooth plunger travel without stick-slip motion.
Graduation Ink Durability: UV-cured graduation ink resists abrasion and contact with alcohols, saline, or clinical solvents.
Reinforced Finger Flanges: Rigid grip flanges absorb manual operational stress without flex or bending deformation.
Intended Use and Applications
Surgical Wound Cleansing: Delivers steady saline streams to clear tissue debris and operative fields.
Urological & Bladder Flushing: Facilitates controlled fluid instillation and evacuation through urinary catheters.
Gastric Lavage & Enteral Nutrition: Supports emergency gastric decompression and formula delivery through feeding tubes.
Controlled Liquid Transfer: Enables precise volumetric metering and liquid handling in non-clinical laboratory environments.
Quality and Regulatory Information
Manufactured in cleanroom facilities operating under ISO 13485 quality standards.
Full technical documentation available to support regional regulatory registration.
Materials pass ISO 10993 evaluations for cytotoxicity, sensitization, and intracutaneous reactivity.
Every lot undergoes validated EO sterilization cycles verified by chemical and biological indicators.
Packaging and Logistics
|
Primary Packaging |
Individual medical-grade pouch with peelable seal indicator. |
|
Inner Packaging |
10 sterile units per protective inner box. |
|
Master Packaging |
50 units per double-wall corrugated export carton. |
|
Carton Gross Weight |
12.5 kg per master carton. |
|
Master Carton Dimensions |
620 mm × 440 mm × 480 mm. |
Customization Options
Private Label Packaging: Custom artwork printing on pouches and outer cartons based on order volume.
Custom Scale Graduation: Specific volumetric intervals, dual units, or custom color printing.
Bulk Non-Sterile Supply: Cleanroom-packed non-sterile components supplied for medical procedure kit assemblers.
Color-Coded Plungers: Plunger color identification for specialized clinical procedural kits.
FAQ
Q: What is the standard tip connection on this 500ml syringe?
A: The device features an extended tapered catheter tip designed for seamless connection to standard catheters, feeding tubes, and irrigation sets.
Q: Are these syringes manufactured without natural rubber latex?
A: Yes, all components and elastomeric seals are manufactured from synthetic polymers, eliminating natural rubber latex allergens and DEHP additives.
Q: What compliance documentation is provided for import clearance?
A: Shipment batches include ISO 13485 certificates, EO sterilization validation reports, biocompatibility test summaries, and Certificate of Analysis (COA) documents.
Q: Can non-sterile units be supplied for custom tray kit assembly?
A: Bulk non-sterile syringes are available double-bagged under cleanroom conditions specifically for procedural kit manufacturers.
Q: How is smooth plunger motion ensured without liquid contamination?
A: An automated micro-dosing system applies controlled quantities of medical-grade silicone oil, maintaining low glide force while keeping lubricant levels within safety limits.
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