Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
Detalhes do produto
Lugar de origem: CHINA
Marca: TENCHY
Certificação: USP CLASS VI
Número do modelo: TCM-C0005
Termos de pagamento e envio
Quantidade de ordem mínima: 500
Preço: Silicone Negative Pressure Drainage Ball
Detalhes da embalagem: Embalagem asséptica / embalagem estéril
Tempo de entrega: 5-8 dias
Termos de pagamento: D/A, D/P, T/T, Western Union, MoneyGram
Habilidade da fonte: 1000 PCs por dia
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) |