Prezentare generală
The Custom Medical Grade PVC Throat Tube with ISO 13485 Certification is engineered for reliable airway access and emergency respiratory support in clinical and hospital environments. Manufactured from biocompatible, DEHP-free medical PVC, the tube provides optimal flexibility, smooth insertion, and stable positioning during emergency procedures. Precision extrusion and automated forming technology ensure consistent inner diameter, wall thickness, and airflow performance. We offer full OEM customization—including tube length, softness (Shore A), connector design, color coding, and printed markings—to meet diverse clinical requirements and regulatory compliance.
Informații de bază
| Atribut | Detalii |
|---|---|
| Material | Medical Grade DEHP-Free PVC |
| Locul de origine | Xiamen, China |
| Numele Mărcii | OEM |
| Mărime | Custom ID/OD & Length |
| Culoare | Transparent / Color-Coded as Required |
| Ambalaj | Sterile pouch, PE bag, blister pack, or custom |
| Logo / Marking | Custom printing (size, scale, indicators) |
| Rezistență la Temperatură | –20 °C to +120 °C |
| OEM | Disponibil |
| MOQ | Small batch orders accepted |
| Probă | Disponibil |
| Tehnologie | Precision PVC Extrusion + Automated Tube Forming |
Beneficii Cheie
- Biocompatible Medical PVC
Safe, DEHP-free formulation suitable for direct patient contact in emergency and clinical applications. - Precision Extrusion Stability
Ensures consistent airflow, smooth internal surfaces, and controlled wall thickness. - Enhanced Flexibility & Kink Resistance
Maintains structural integrity during rapid emergency interventions. - Full OEM Tailoring
Size, durometer, connectors, markings, and packaging customizable to hospital or device-brand requirements.
Asigurarea Calității
Our Custom Medical Grade PVC Throat Tube is manufactured under a validated ISO 13485 quality management system tailored to medical device production. All materials meet FDA and EU medical-grade requirements for biocompatibility and cytotoxicity.
Each production batch undergoes rigorous inspection using advanced measurement and testing equipment, including:
- ID/OD dimensional verification using high-precision laser gauges
- Tensile strength & elongation tests to ensure durability
- Kink-resistance and bending tests for airway safety
- Flow-rate and pressure-drop evaluation to confirm airway efficiency
- Biocompatibility checks (ISO 10993 compliant)
- 100% visual inspection for clarity, uniformity, and contamination control
All tubes are available with EO sterilization, and every shipment includes complete traceability, lot records, and COA documentation.
Why Partner with Us for Your Medical PVC Manufacturing Needs?
1. Medical Manufacturing Expertise Built Over 20+ Years
We bring decades of experience in medical-grade plastics processing, delivering stable, compliant, and high-precision products used across hospitals and emergency care systems.
2. Fully Customizable OEM Solutions
From connector designs to tube softness and printed visual indicators, our team provides end-to-end engineering support tailored to your device requirements and regional regulatory needs.
3. Streamlined and Transparent Project Flow
We manage everything—from raw material sourcing and mold fabrication to extrusion, finishing, sterilization, and packaging—with clear communication and rapid lead times.
4. Certified Quality & Full Regulatory Compliance
Supported by ISO 13485 and a strict documentation system, every product meets international standards required for Class I/II medical consumables.
Fabrica Spectacol
Our medical-grade facility is equipped with a complete lineup of precision production and inspection equipment designed for high-tolerance PVC medical tube manufacturing:
- Multi-layer precision PVC extrusion lines
- Automated tube-forming and connector-bonding systems
- Ultrasonic cleaning and drying systems for medical devices
- CNC machining centers for custom connectors and molds
- Class 100,000 cleanroom assembly & packaging
Quality control is supported by advanced testing instruments:
- 3D optical measurement systems
- Laser ID/OD gauges
- Tensile/elongation testers
- Pressure & airflow testers
- EO sterilization equipment
Our facility is certified to ISO 13485 and ISO 9001, ensuring consistent manufacturing, full traceability, and compliance with global medical device standards.
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