Disposable Two-Lumen Silicone Foley Catheter 8-26Fr with 6ATM Balloon Pressure and ISO 10993 Certification
Price:
NEGOTIATBLE
MOQ:
500
Delivery Time:
5-8 days
Brand:
TENCHY
Product Description
Disposable Two-Lumen Silicone Foley Catheter
Medical-grade silicone catheter featuring dual-lumen design for precision fluid management and clinical efficiency.
Core Advantages
- Medical-grade silicone material with ISO 10993 biocompatibility
- Dual-lumen system for separate inflation and drainage functions
- Enhanced visualization with X-ray markers and measurement scales
Innovative Structure & Material
| Feature | Technical Specifications |
|---|---|
| Dual-Channel System | Inflation lumen with spherical balloon and precision pressure control; Drainage lumen with high-flow design (>8mm²) and anti-clog features |
| Medical Silicone Tubing | ISO 10993 certified with zero cytotoxicity, sensitization, or irritation; Low protein adsorption surface (≤3μg/cm²) |
| 360° Symmetrical Balloon | Radial expansion deviation |
Clinical Enhancements
- Visualization System: Embedded barium sulfate line (X-ray visible length ≥35cm) with biomarker scale (5mm graduations, ±0.3mm tolerance)
- Kink-Resistant Tubing: Flexural strength ≥150N (ASTM D790); Chemical resistance to glutaraldehyde/peracetic acid disinfectants
- Sterility Assurance: EO sterilization (residue ≤0.1ppm); Dual sterile barrier packaging (ISO 11607)
Enhanced Specifications
Core Parameters
| Size (Fr) | Outer Ø (mm) | Lumen Area (mm²) | Balloon Vol (ml) | Max Flow (ml/min) | Connector Type |
|---|---|---|---|---|---|
| 8Fr | Ø2.67 | 3.5 | 3-5 | 35 | Standard Luer lock |
| 12Fr | Ø4.00 | 8.4 | 5-10 | 85 | Anti-reflux valve |
| 16Fr | Ø5.33 | 14.1 | 5-15/30 | 150 | Rotary diverter |
| 20Fr | Ø6.67 | 22.1 | 5-15/30 | 240 | Suction port |
| 26Fr | Ø8.67 | 37.9 | 5-15/30 | 400 | Irrigation 3-way |
Performance Validation
| Test Item | Standard Value | Compliance Standard |
|---|---|---|
| Balloon Fatigue Resistance | >5,000 inflation/deflation cycles | ISO 20695 |
| Tensile Strength | ≥15N/mm² | GB/T 1040.3 |
| Short-term Biofilm Formation | ASTM E2180 | |
| Acute Hemolysis Rate | ≤0.8% (vs. 5% threshold) | ISO 10993-4 |
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Get in Touch
Have questions about our products or want to discuss a custom order? Our team is ready to help you.
Company
Shenzhen Tenchy Silicone&Rubber Co.,Ltd
Location
Building 8, Tongfucun Industrial Park, Longhua, Shenzhen, Guangdong, China (518109)
Contact Person
Justin Wu