Overview:
Customized Medical Grade PVC Cuffed Endotracheal Anesthesia Throat Tube with Inner Cannula Fenestrated Tracheostomy Tube is a high-quality, precision-engineered medical device designed for airway management in anesthesia and tracheostomy care. Manufactured from medical-grade PVC, these tubes are designed to provide superior comfort, safety, and performance during intubation procedures. The cuffed design ensures an airtight seal to prevent air leakage, while the fenestrated inner cannula allows for better ventilation and easier suctioning. Utilizing advanced extrusion and injection molding techniques, our tubes are fully customizable in length, size, and cuff characteristics, ensuring optimal fit for different patient needs. Our factory is ISO 13485 certified, offering comprehensive OEM services to meet the highest standards of safety, reliability, and functionality.
Basic Information:
| Attribute | Details |
|---|---|
| Material | Medical-Grade PVC |
| Place of Origin | Xiamen, China |
| Brand Name | OEM |
| Cuff Type | Cuffed with Inner Cannula |
| Size | Custom |
| Sterilization | EO (Ethylene Oxide) Sterilized |
| Color | Transparent |
| Application | Anesthesia, Tracheostomy |
| OEM | Available |
| MOQ | Small Orders Accepted |
| Certification | ISO 13485, CE |
| Technology | Extrusion Molding, Cuff Inflation Technology,Injection Molding |
| Sample | Available |
Benefits of Our Products:
- Medical-Grade Material Integrity
Crafted from high-quality, medical-grade PVC, these tubes meet international medical safety standards, ensuring no toxicity or irritation for the patient. - Cuffed Design for Optimal Seal
The cuffed design provides a secure, leak-proof seal, preventing air from escaping around the tube and ensuring efficient ventilation during anesthesia and tracheostomy care. - Fenestrated Inner Cannula for Improved Ventilation
The fenestrated inner cannula enhances airflow and facilitates suctioning, reducing the risk of airway obstruction and promoting better oxygenation. - Customizable Precision
We offer full customization in tube length, cuff size, and the inner cannula’s fenestration pattern to meet specific patient needs, ensuring a perfect fit for each procedure.
Quality Assurance:
Our manufacturing process for the Customized Medical Grade PVC Cuffed Endotracheal Anesthesia Throat Tube is supported by comprehensive quality control protocols, certified under ISO 13485 standards. We begin by verifying all raw materials for compliance with FDA and CE regulations. Throughout the production process, we perform rigorous in-process testing, including dimensional accuracy checks using CNC Coordinate Measuring Machines (CMM), and inflating tests to ensure the cuff maintains pressure integrity. Finished products undergo sterilization verification, visual inspection for defects, and leak testing under simulated physiological conditions. Each batch is subjected to further microbial testing to ensure sterility before packaging and shipment.
Our Advantages:
- Over Two Decades of Industry Expertise
With over 20 years of experience in the medical device manufacturing industry, we are experts in producing high-performance, reliable medical products designed for both patient safety and operational efficiency. - Comprehensive OEM Customization
We offer full OEM services, including customization of size, cuff type, and fenestration design, as well as logo branding and packaging solutions tailored to your specific market needs. - Efficient Project Management
From prototyping and design validation to mass production, our streamlined project management system ensures timely, clear communication, and on-schedule deliveries. - Certified Quality Control
Adhering to ISO 13485 certifications, our quality management system guarantees products meet the highest medical device standards, ensuring optimal performance and safety.
Factory Show:
Our advanced manufacturing facility is equipped with cutting-edge technologies, including CNC machining centers, mirror-finish EDM, and high-precision wire-cutting systems, ensuring exceptional accuracy in mold fabrication. With a production floor featuring high-speed injection molding systems and automated inflation systems, we ensure tight tolerances and consistent performance across all production runs. Our stringent quality control procedures include 3D optical projectors, sealing testers, and leak testing systems, all managed by certified quality assurance specialists. Fully accredited to ISO 13485, we operate under strict compliance with FDA and CE regulations, ensuring that every product is safe, effective, and reliable for use in critical medical applications. Additionally, our class 8 cleanroom environment guarantees that each component is produced in a contamination-free environment.
