Product Description of Silicone Negative Pressure Drainage Ball 1. Product Positioning & Core ApplicationDesigned for clinical negative pressure drainage, it connects to
in-vivo drainage catheters to transmit negative pressure and
collect drainage fluids (e.g., effusions, exudates) efficiently.
Widely used in operating rooms, general surgery, neurosurgery,
gynecology, anorectal surgery, and urology to support fluid
management during post-operation and clinical treatment. 2. Core Advantages High-Quality Material Assurance,Strong Compatibility,User-Friendly
Design 3. Key Product Features- Stable Performance: High transparency (for observing drainage fluid quality), good
elasticity, pressure resistance, anti-aging, oxidation resistance,
corrosion resistance, and tolerance to weak acids/alkalis.
- Optimized Structure: Soft tube mouth reduces wound pressure; 3-in-1 integrated
structure ensures excellent anti-torsion; 4 internal breakpoints +
fully open drainage grooves enable thorough fluid drainage.
- Safe Connecting Tube: Disposable suction connecting tube is made of medical polymer
silicone – non-toxic, odorless, non-irritating, ensuring overall
safety.
4. Key Information Tables 4.1 Basic Product Specification Table | Item | Details | | Product Name | Silicone Negative Pressure Drainage Ball | | Main Materials | Medical-grade Silicone, PVC | | Brand Cooperation | OEM (Customized Brand Supported) | | Sterilization Method | EO (Ethylene Oxide) Sterilization ("EOS" is a wording optimization;
subject to actual EO process) | | Product Nature | Medical Materials & Accessories, Medical Polymer Materials
& Products | | Device Classification | Class II Medical Device | | Shelf Life | 3 Years (Unopened, Stored as Specified) | | Quality Certifications | CE, FDA, ISO 13485 | | Sample Policy | Free Samples Provided (for performance testing, clinical trial) | | Safety Standard | No Specific Label (Compliant with General Safety Requirements for
Class II Devices) |
4.2 Clinical Application Table| Applicable Department | Core Use | | Operating Room | Intraoperative & post-op immediate fluid drainage | | General Surgery | Post-abdominal surgery effusion management | | Neurosurgery | Fluid drainage during cranial treatment | | Gynecology | Post-gynecological surgery (e.g., pelvic) drainage | | Anorectal Surgery | Post-op exudate collection | | Urology | Fluid management during urological treatment |
4.3 Simple Operation Steps Table| Step | Key Operations | | 1 | Check package for damage/abnormality; open and confirm internal
product integrity | | 2 | Firmly connect the drainage tube to the device’s drainage port; fix
the hanger in place | | 3 | Close Robert clamp → Open hole plug ring → Squeeze the bottle →
Cover hole plug ring to let fluid enter via one-way valve | | 4 | When fluid nears marked volume: Replace tube for A1/A2 models;
Record volume then open Robert clamp to drain waste for B1/B2
models |
4.4 Certification & Testing Table| Certification/Testing Type | Specific Items | | Int’l Quality & Access Certifications | ISO 13485 (QMS), FDA (U.S. Market Access), LFGB (EU Safety
Standard) | | Biocompatibility Testing | Skin Irritation Test, Skin Sensitization Test, Pyrogen Test,
Hemolysis Test, MTT Cytotoxicity Test (All Passed) |
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