Disposable Super-Slippery Sterile Triple-Lumen Silicone Catheter
I. Core Product Features & Description (Enhanced)
1. Premium Material - 100% Medical Grade Silicone: Excellent biocompatibility, exceeding ISO 10993 standards. Soft
and comfortable for long-term indwelling, reducing tissue irritation and infection risk. High
physicochemical stability.
2. Revolutionary Lubrication - Hydrophilic Polymer Coating: Activated instantly by water or saline, forming a low-friction
hydrogel layer (friction reduction >90%). Enables virtually painless insertion and removal and provides lasting comfort during wear.
3. Sophisticated Design - Triple Lumen Structure:
· Drainage Lumen: For urine outflow.
· Balloon Inflation/Deflation Lumen: For filling/emptying the retention balloon with sterile
water/saline.
· Irrigation/Aspiration Lumen: For bladder irrigation with fluids (e.g., saline), instillation
of medication (e.g., antibiotics), aspiration of residual fluid, or
sampling.
4. Safety Assurance - Pre-Sterilized Packaging: Sterilized using Ethylene Oxide (EO) for sterility assurance (SAL ≤ 10⁻⁶). Each catheter is individually sealed for immediate use upon opening.
5. Compliance & Versatility: Widely applicable in hospitals, clinics, surgery centers,
rehabilitation, and long-term care facilities. Compliant with CE Mark (EU MDD/MDR), ISO 13485:2016, FDA regulations, and LFGB (material safety). Material passes relevant ISO 10993
biocompatibility tests.
6. Safety Features: Soft rounded tip design (often Coude/Straight), color-coded
balloon zone for positioning, clearly labeled inflation valve.
II. Detailed Product Specifications
| Category | Parameter Details |
| Basic Information | |
| Product Model | TCM-002 |
| Full Product Name | Disposable Super-Slippery Hydrophilic-Coated Sterile Triple-Lumen
Silicone Catheter |
| Brand | TENCHY or OEM |
| Material | 100% Medical Grade Silicone |
| Catheter Size (French) | Fr 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 (Note: Verify balloon options for Fr8-12) |
| Catheter Working Length | 400 mm (40 cm) |
| Balloon Volume (ml) | Varies by Fr Size: |
| * 14Fr: 5ml / 5-10ml / 15ml |
| * 16Fr: 5ml / 5-10ml / 20ml / 30ml |
| * 18Fr: 5ml / 5-10ml / 20ml / 30ml |
| * 20Fr: 10ml / 30ml |
| * 22Fr: 10ml / 30ml |
| * 24Fr: 10ml / 30ml |
| * 26Fr: 10ml / 30ml |
| Balloon Characteristics | Compliant design, Balloon Burst Pressure ≥ 5ATM (standard test). Only use sterile water/saline. Never use air. |
| Usage Attribute | Single Use Only |
| Product Type | Urological Catheter, Drainage Tube |
| Supply Capacity | 10,000 pcs / day |
| Minimum Order Quantity (MOQ) | 100 pcs |
| Delivery Time | 5-8 days |
| Payment Terms | L/C, T/T, Western Union, MoneyGram, PayPal |
| Packaging Details | |
| Inner Packing | 10 pcs/box (Individually sterile sealed) |
| Outer Packing (Options) | |
| * 20 boxes / carton = 200 pcs/carton
(Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate |
| * 40 boxes / carton = 400 pcs/carton
(Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate |
| * 50 boxes / carton = 500 pcs/carton
(Volume: _ cm x _ cm x _ cm, GW ~ _ kg) Estimate |
| * Customizable Packaging Supported |
| Certification & Testing | |
| Quality Management System | ISO 13485:2016 Certified |
| Regulatory Approvals | CE Mark (Complies with EU MDD 93/42/EEC or MDR 2017/745, Class IIa/IIb)
FDA Registered
LFGB (Proof of material food safety compliance) |
| Biocompatibility Testing | Compliant with ISO 10993 series standards, Test reports available (upon request) including: |
| * Cytotoxicity - MTT Test, etc.
* Sensitization
* Irritation
* Pyrogenicity (In-vivo/In-vitro)
* Hemocompatibility - Hemolysis Test |
