Specifications
Brand Name :
TENCHY
Model Number :
TCM-002
Certification :
USP CLASS VI
Place of Origin :
CHINA
MOQ :
500
Price :
NEGOTIATBLE
Payment Terms :
D/A, D/P, T/T, Western Union, MoneyGram
Supply Ability :
1000 pcs per day
Delivery Time :
5-8 days
Packaging Details :
10 pcs/box (Individually sterile sealed)
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, 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

Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

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Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

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Brand Name :
TENCHY
Model Number :
TCM-002
Certification :
USP CLASS VI
Place of Origin :
CHINA
MOQ :
500
Price :
NEGOTIATBLE
Contact Supplier
Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating
Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating
Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating
Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating
Sterile Triple-Lumen Silicone Catheter with Hydrophilic Coating

Shenzhen Tenchy Silicone&Rubber Co.,Ltd

Verified Supplier
10 Years
guangdong, shenzhen
Since 2008
Business Type :
Manufacturer
Employee Number :
50~100
Certification Level :
Verified Supplier
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