Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
उत्पाद विवरण
उत्पत्ति के प्लेस: चीन
ब्रांड नाम: TENCHY
प्रमाणन: USP CLASS VI
Model Number: TCM-003
भुगतान और शिपिंग शर्तें
न्यूनतम आदेश मात्रा: 500
मूल्य: NEGOTIATBLE
Packaging Details: Individually sterile sealed
प्रसव के समय: 5-8 दिन
भुगतान शर्तें: डी/ए, डी/पी, टी/टी, वेस्टर्न यूनियन, मनीग्राम
आपूर्ति की क्षमता: 1000 पीसीएस प्रति दिन
This product is a single-use sterile drainage system composed of medical-grade silicone and polymer PVC components. It generates negative pressure through manual compression for closed drainage and collection of postoperative wound exudate, blood, and body cavity fluids. Its core advantage lies in self-controlled physical negative pressure, requiring no external power device, ensuring safe and convenient operation for multi-scenario clinical drainage needs.
| Feature | Detailed Specifications |
| Biocompatibility | Compliant with ISO 10993 standards; non-cytotoxic, non-sensitizing, suitable for long-term tissue contact. |
| Precision Graduation | Laser-etched graduations (±2% accuracy) on bulb body; resistant to alcohol wiping; available in 20ml/50ml/100ml/200ml capacities. |
| Anti-Reflux Design | Silicone one-way valve (sealing pressure ≥0.02MPa) prevents fluid backflow; Luer-lock connector secures tubing. |
| Mechanical Performance | Elastic recovery >90% (ASTM D395); compressive strength ≥80kPa; withstands >200 compression cycles. |
| Innovative Tubing | Triple fracture grooves support 360° bending; fully open drainage channels enhance flow efficiency by 40% for viscous fluids. |
| Sterilization Safety | EO sterilization; residue <2μg/g (ISO 10993-7); sterile barrier packaging with 3-year shelf life. |
| Parameter Category | Technical Standards |
| Models | A1 (Fixed Capacity) / A2 (Drainable) / B1 (High-Capacity) / B2 (Pediatric) |
| Material Composition | Bulb: Platinum-cured silicone (USP Class VI) Tubing/Accessories: Medical PVC (DEHP-Free) |
| Capacity Options | 80ml/150ml/200ml/400ml (±5% volume tolerance) |
| Negative Pressure | Initial: -50±10mmHg Sustained: -15~-25mmHg (>85% stability within 8 hours) |
| Connection Standard | ISO 80369 Luer connector (with anti-reflux valve); compatible with 8Fr-24Fr catheters. |
| Physical Resistance | Corrosion resistance: No degradation in pH 2-12 solutions (72h immersion) Temperature: -20℃~+50℃ (storage) / 0℃~40℃ (use) |
| Certifications | CE 0476 (MDD 93/42/EEC), FDA 510(k), ISO 13485:2016 Complies with YY/T 0466.1 medical device labeling |
| Packaging | 1 unit/sterile pouch, 20 units/inner box, 200 units/master carton |
| Clinical Indications | Postoperative wound drainage (breast/thyroid/joint replacement), traumatic hematoma, abscess drainage, ascites. |
| Contraindications | Actively bleeding wounds, uncontrolled infected wounds, tumor resection areas (requires physician evaluation). |
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