Engineered for optimal hemodynamics, reduced recirculation, and exceptional biocompatibility. Fully customizable in French sizes, lumen geometries, and packaging configurations.
15Fr implant-grade silicone construction featuring transcutaneous tissue-ingrowth Dacron cuff, split-tip lumen geometry, and minimal recirculation (<3%) for chronic venous access.
Comprehensive acute dialysis procedural tray including thermosensitive PU catheter, J-tip nitinol core guidewire, vessel dilator, scalpels, and heparin lock caps.
Double-lumen Carbothane™ polyurethane catheter providing superior tensile strength during insertion, softening at body temperature to minimize endothelial wall trauma.
Versatile acute vascular access suite offered in single (7Fr), double (11.5Fr/12Fr), and triple (12Fr) lumen configurations tailored for CRRT and high-volume plasmapheresis.
CE MDR 2017/745 registered 12Fr x 20cm straight dual-lumen access catheter. Formulated with 28% Barium Sulfate compounding for full fluoroscopic visualization.
Comprehensive length matrix (19cm to 35cm tip-to-cuff length) designed to accommodate diverse patient anatomical profiles while ensuring high target blood flows (>400 mL/min).
High-grade permanent indwelling vascular access assembly coupled with breathable microporous surgical fixation dressings engineered to minimize CRBSI risk.
Cost-optimized OEM dialysis catheter procedure kit manufactured in ISO Class 7 cleanrooms. Fully compliant with WHO-GMP and international tender specifications.
In the high-stakes domain of Renal Replacement Therapy (RRT) and End-Stage Renal Disease (ESRD) care, vascular access integrity directly determines patient survival and clinical clearance efficacy ($Kt/V$). As a global medical device manufacturer, Sterimed Group leverages over six decades of polymer processing, cleanroom micro-extrusion, and biological safety compliance to deliver OEM/ODM dialysis catheter platforms that meet the world's most stringent regulatory standards.
The selection of vascular contact material dictates both acute insertion safety and long-term biocompatibility:
Hemodialysis vascular access requires high blood flow rates ($300\text{--}450 \text{ mL/min}$) without inducing mechanical hemolysis or plateled activation:
Our custom OEM dialysis catheter extrusion lines support extensive size ranges, lumen configurations, and customizable procedural kit components. Below are standard technical parameters validated in our testing facilities.
| French Size (Fr) | Catheter Material | Lumen Type | Effective Length | Recommended Flow Rate | Priming Vol. (Art/Ven) | Clinical Application |
|---|---|---|---|---|---|---|
| 7.0 Fr - 8.5 Fr | Thermosensitive TPU | Double Lumen | 10 cm - 15 cm | 100 - 200 mL/min | 0.8 mL / 0.9 mL | Pediatric Acute Hemodialysis & CRRT |
| 11.5 Fr - 12.0 Fr | Polyurethane / Carbothane™ | Double / Triple Lumen | 13 cm - 20 cm | 250 - 350 mL/min | 1.3 mL / 1.4 mL | Adult Acute Subclavian / Jugular Access |
| 13.5 Fr | Soft Polyurethane | Double Lumen Step-Tip | 15 cm - 25 cm | 300 - 400 mL/min | 1.5 mL / 1.6 mL | Short to Medium-Term Clinical Dialysis |
| 14.5 Fr - 15.0 Fr | Medical-Grade Silicone | Split-Tip / Double Lumen | 19 cm - 35 cm | 350 - 450 mL/min | 1.8 mL / 1.9 mL | Long-Term Tunneled Chronic HD with Dacron Cuff |
| 16.0 Fr | Polycarbonate Polyurethane | Symmetric Zero-Recirc | 23 cm - 36 cm | 400 - 500 mL/min | 2.0 mL / 2.1 mL | High-Flux Chronic HD Access & Apheresis |
All dialysis catheters can be customized with color-coded extension line clamps (red for arterial, blue for venous), custom laser depth markings, radiopaque stripe ratios, heparin-free antimicrobial coating options, and bespoke procedural tray packaging (including Nitinol guidewires, PTFE tearaway sheaths, vessel dilators, and scalpels).
As global nephrology networks adapt to aging demographics and increasing chronic kidney disease prevalence, procurement teams must align with emerging technological advancements and regulatory mandates.
The industry is transitioning rapidly toward non-leaching hydro-gel coatings, hydrophilic polymer grafting, and zwitterionic surface treatments. These advances minimize protein adsorption, reduce thrombus formation by over 80%, and significantly diminish reliance on systemic anticoagulation during dialysis sessions.
Traditional step-tip designs suffer from severe flow degradation when lines are reversed due to access thrombosis. Next-generation OEM requests heavily prioritize symmetric tip geometries that maintain identical hydraulic performance (under 2% recirculation) in both forward and reversed blood line connections.
The transition to the European Union's CE MDR (2017/745) Class III medical device requirements demands comprehensive clinical evaluation reports (CER), strict toxicological risk assessments (ISO 10993), and robust post-market clinical follow-up (PMCF). Partnering with audited OEM factories with existing technical dossiers is critical.
Operating under strict ISO 13485 and WHO-GMP guidelines, Sterimed Group provides vertically integrated OEM/ODM services from tooling design to sterile shelf-ready packaging.
Our state-of-the-art extrusion lines process medical-grade TPU, Carbothane™, and platinum-cured silicone with extreme dimensional accuracy:
Ensuring absolute biological safety and batch-to-batch repeatability for high-volume hospital deployments:
Essential guidance for medical device distributors, procurement officers, and OEM contract buyers.
Our manufacturing plants operate under certified ISO 13485 and ISO 9001 Quality Management Systems, hold WHO-GMP compliance, and maintain CE Marking under EU Directive/MDR for applicable Class III hemodialysis catheter families. Full technical files, master masterbatch safety data, and sterilization validation reports are supplied to support OEM brand regulatory registrations.
Polyurethane (specifically thermosensitive TPU) provides superior column strength and pushability for acute vascular access, softening at body temperature to minimize endothelial abrasion. Silicone catheters are softer, chemically inert, and feature higher flexural longevity, making them the preferred choice for long-term tunneled indwelling vascular access with tissue-ingrowth Dacron cuffs.
Our catheters utilize precision-engineered tip geometries (Step-Tip, Split-Tip, or Symmetric configurations) that maintain a physical spatial separation between the arterial suction port and venous return port. Validated fluid dynamic testing demonstrates recirculation rates under 3% at blood flow speeds up to 400 mL/min.
Yes. As a custom OEM/ODM manufacturer, we supply tailored procedural trays including customizable components (scalpels, Nitinol core guidewires, vessel dilators, injection caps, drape sheets) with custom-printed Tyvek pouches, multilingual IFUs (Instructions for Use), and localized branded export cartons.
All single-use dialysis catheter kits undergo terminal Ethylene Oxide (EO) sterilization in validated industrial chambers according to ISO 11135 standards. Each batch is released with EO residual testing reports, biological indicator verification, and a 3-year to 5-year shelf-life stability validation based on real-time and accelerated aging data.
We compound medical polyurethane and silicone resins with 20% to 30% Barium Sulfate ($BaSO_4$) or Bismuth Trioxide ($Bi_2O_3$). This guarantees clear fluoroscopic visualization along the entire length of the catheter shaft and tip under standard X-ray imaging in the ICU or cath lab.
Standard OEM production runs typically start at 1,000 to 5,000 sets per specific size and configuration depending on custom tooling and packaging requirements. Sample lead times for existing configurations are 1-2 weeks, while customized OEM production orders are fulfilled within 30-45 days post-artwork confirmation.
International procurement teams and brand owners can directly click the Get Catalog button on this page to initiate an immediate inquiry with our dedicated OEM export desk, or request full product specs, sample evaluation units, and CE technical files.
Accelerate your market access with validated ISO 13485 OEM vascular access solutions, custom cleanroom micro-extrusion, and competitive contract pricing.