Medical Silicone Negative Pressure Drainage Bulb 80ml-400ml Capacity with ISO 80369 Luer Connector for Wound Exudate
Price:
NEGOTIATBLE
MOQ:
500
Delivery Time:
5-8 days
Brand:
TENCHY
Product Description
This single-use sterile drainage system is 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. The 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.
Enhanced Core Features
| 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 |
Technical Specifications
| 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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Company
Shenzhen Tenchy Silicone&Rubber Co.,Ltd
Location
Building 8, Tongfucun Industrial Park, Longhua, Shenzhen, Guangdong, China (518109)
Contact Person
Justin Wu