Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
제품 세부 정보
원래 장소: 중국
브랜드 이름: TENCHY
인증: USP CLASS VI
모델 번호: TCM-C0005
지불 및 배송 조건
최소 주문 수량: 500
가격: Silicone Negative Pressure Drainage Ball
포장 세부 사항: 무균 포장 / 멸균 포장
배달 시간: 5-8 일
지불 조건: D/A, D/P, T/T, Western Union, MoneyGram
공급 능력: 일 당 1000 PC
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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