Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating - Fr 8-26 Sizes, 400mm Length, ISO 13485 Certified
Manufactured from 100% medical grade silicone with excellent biocompatibility, exceeding ISO 10993 standards for patient safety and comfort during extended use.
Water-activated polymer coating creates a low-friction hydrogel layer, reducing insertion friction by over 90% for enhanced patient comfort.
Ethylene Oxide sterilized with sterility assurance level ≤ 10⁻⁶, individually sealed for immediate clinical use.
| Product Model | TCM-002 |
|---|---|
| Material | 100% Medical Grade Silicone |
| Catheter Sizes | Fr 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
| Working Length | 400 mm (40 cm) |
| Balloon Volume Options |
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 Pressure | Burst pressure ≥ 5ATM (standard test) |
| Usage | Single Use Only |
| Production Capacity | 10,000 units per day |
| Minimum Order | 100 units |
| Delivery Time | 5-8 days |
ISO 13485:2016 certified manufacturing facility with CE Mark compliance (EU MDD/MDR), FDA registration, and comprehensive biocompatibility testing including cytotoxicity, sensitization, irritation, and hemocompatibility assessments.
Individually sterile sealed units, available in multiple carton configurations: 200 units/carton, 400 units/carton, or 500 units/carton. Custom packaging solutions supported.
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