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Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

Name: Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating
Brand: Shenzhen Tenchy Silicone&Rubber Co.,Ltd
SKU: TCM-002
Price: 5,508.00 USD
Availability: InStock

Product Details

Place of Origin: CHINA

Brand Name: TENCHY

Certification: USP CLASS VI

Model Number: TCM-002

Payment & Shipping Terms

Minimum Order Quantity: 500

Price: NEGOTIATBLE

Packaging Details: 10 pcs/box (Individually sterile sealed)

Delivery Time: 5-8 days

Payment Terms: D/A, D/P, T/T, Western Union,

Supply Ability: 1000 pcs per day

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Product Details

Product Description

Product Details

Highlight: 
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Product Description

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, , 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

Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

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Tel: 86-18129801081

Fax: 86-0755-28237626

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Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating