Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
製品詳細
起源の場所: 中国
ブランド名: TENCHY
証明: USP CLASS VI
モデル番号: TCM-C0005
支払いと送料の条件
最小注文数量: 500
価格: Silicone Negative Pressure Drainage Ball
パッケージの詳細: 無菌パッケージ /滅菌パッケージ
受渡し時間: 5-8日
支払条件: D/A、D/P、T/T、Western Union、MoneyGram
供給の能力: 日あたり1000個
Designed 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.
High-Quality Material Assurance,Strong Compatibility,User-Friendly Design
| 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) |
| 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 |
| 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 |
| 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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