Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
Product Details
Place of Origin: CHINA
Brand Name: TENCHY
Certification: USP CLASS VI
Model Number: TCM-005
Payment & Shipping Terms
Minimum Order Quantity: 500
Price: NEGOTIATBLE
Packaging Details: 10 pcs/box (Individually sterile sealed)
Delivery Time: 5-8 days
Payment Terms: D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability: 1000 pcs per day
Core Advantages: Medical-grade Silicone × Dual-Lumen Fluid Dynamics × Visual Operation Support
Feature |
Technical Specifications
|
Dual-Channel System |
① Inflation Lumen: Spherical balloon with precision pressure control, anti-collapse
|
Medical Silicone Tubing |
ISO 10993 biocompatibility certified:
|
360° Symmetrical Balloon | Radial expansion deviation <5%,burst pressure ≥6ATM (Complies with YY 0325) |
· Visualization System:
o Embedded barium sulfate line (X-ray visible length ≥35cm)
o Biomarker scale (5mm graduations, ±0.3mm tolerance)
· Kink-Resistant Tubing:
o Flexural strength ≥150N (ASTM D790)
o Chemical resistance: Compatible with glutaraldehyde/peracetic acid disinfectants
· Sterility Assurance:
o EO sterilization (residue ≤0.1ppm)
o Dual sterile barrier packaging (ISO 11607)
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 |
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 | <10² CFU/cm² (72hrs) | ASTM E2180 |
Acute Hemolysis Rate | ≤0.8% (vs. 5% threshold) | ISO 10993-4 |