Shenzhen Tenchy Silicone&Rubber Co.,Ltd sales@tenchy.cn 86-755-29181281
تفاصيل المنتج
مكان المنشأ: الصين
اسم العلامة التجارية: TENCHY
إصدار الشهادات: USP CLASS VI
رقم الموديل: TCM-C0004
شروط الدفع والشحن
الحد الأدنى لكمية: 500
الأسعار: NEGOTIATABLE
تفاصيل التغليف: التعبئة التعبئة المعقمة / التعبئة المعقمة
وقت التسليم: 5-8 أيام
شروط الدفع: D / P ، D / A ، T / T ، ويسترن يونيون ، موني جرام
القدرة على العرض: 1000 قطعة في اليوم
Precision Operation Guarantee,Multi-Layer Sterile Protection,Full-Scenario Adaptability
| French Size (Fr) | Length (mm) | Outer Diameter (mm) | Product Code | Target Population |
| 6Fr | 400 | 2.0 | JE-005-06 | Infants and low-weight patients |
| 8Fr | 400 | 2.6 | JE-005-08 | Infants and adolescents |
| 10Fr | 400 | 3.3 | JE-005-10 | Adolescents and adults (small airways) |
| 12Fr | 400 | 4.0 | JE-005-12 | Adults |
| 14Fr | 400 | 4.6 | JE-005-14 | Adults |
| 16Fr | 400 | 5.3 | JE-005-16 | Adults (medium airways) |
| 18Fr | 400 | 5.9 | JE-005-18 | Adults (larger airways) |
| 20Fr | 400 | 6.6 | JE-005-20 | Adults (large airways) |
| 22Fr | 400 | 7.3 | JE-005-22 | Adults |
| Item | Details |
| Product Name | Suction Catheter / Sputum Suction Tube |
| Main Materials | Medical-grade Silicone, Medical-grade PVC |
| Brand Cooperation Model | OEM (supports customized branding) |
| Sterilization Method | EO (Ethylene Oxide) Sterilization (Original "EOS" is a wording optimization; subject to the actual EO sterilization process) |
| Product Nature | Medical Materials and Accessories, Medical Polymer Materials and Products |
| Medical Device Classification | Class II |
| Shelf Life | 3 years (under unopened condition and in compliance with specified storage requirements) |
| Basic Quality Certification | CE Certification |
| Sample Policy | Free samples provided (supporting performance testing, quality evaluation, and clinical trials) |
| Safety Standard | No specific label (compliant with general safety requirements for Class II medical devices) |
| Certification/Testing Type | Specific Items and Descriptions |
| International Quality System Certification | ISO 13485 (Medical Device Quality Management System Certification, covering the entire process of design, production, and inspection) |
| International Market Access Certification | 1. FDA (U.S. Food and Drug Administration Certification, compliant with U.S. medical device market access requirements)2. LFGB (German Federal Institute for Risk Assessment Certification, compliant with relevant EU safety standards) |
| Biocompatibility Testing | 1. Skin Irritation Test2. Skin Sensitization Test3. Pyrogen Test4. Hemolysis Test5. MTT Cytotoxicity Test (All tests passed, verifying human safety) |
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