Silicone Negative Pressure Drainage Bulb Product DescriptionThis 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.
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 <2μg/g (ISO 10993-7); sterile barrier
packaging with 3-year shelf life. |
Upgraded 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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