Endobronchial Tube

The Endobronchial Tube is a specialized airway management device designed for selective lung ventilation, primarily used to isolate the left or right bronchus during thoracic surgery, trauma rescue, or critical care. By establishing a separate ventilation pathway for one lung, it protects the healthy lung from contamination (e.g., blood, pus) and creates a clear surgical field for procedures such as lobectomy, pneumonectomy, or thoracoscopy. Crafted from medical-grade biocompatible materials, it features a precision-engineered structure with an inflatable cuff, clear anatomical markings, and universal connectors, ensuring reliable lung isolation, minimal airway trauma, and seamless compatibility with ventilation equipment. Suitable for adults and pediatric patients, it is an indispensable tool in operating rooms, ICUs, and emergency departments, complying with ISO 13485, CE, and NMPA medical device standards.

The device's ergonomic design is tailored to human tracheobronchial anatomy: a flexible main tube (single-lumen or double-lumen) with a tapered distal tip facilitates atraumatic insertion into the target bronchus; the low-pressure high-volume cuff expands evenly to form a leak-proof seal, avoiding mucosal ischemia while ensuring effective lung isolation; clear depth markings and bronchial alignment indicators enable precise positioning under fiberoptic bronchoscopy. The proximal end is equipped with a 15mm ISO standard connector for compatibility with ventilators and anesthesia circuits, and a Y-adapter (for double-lumen tubes) allows independent ventilation of each lung. Each unit is pre-sterilized via EO gas, ready for immediate use with no complex assembly, critical for time-sensitive surgical and emergency scenarios. Rigorous quality testing ensures structural integrity, sealing performance, and biocompatibility, guaranteeing safe and effective clinical application.

 

 

• Reliable Lung Isolation: Low-pressure high-volume cuff design achieves a tight seal at 20-30 cmH₂O, with a leakage rate ≤2%, effectively isolating the target lung from the contralateral side. Prevents cross-contamination between lungs and ensures a clear surgical field during thoracic procedures.
• Atraumatic Airway Protection: Tapered, smooth distal tip and flexible tube minimize trauma to tracheal and bronchial mucosa during insertion. The low-pressure cuff reduces the risk of mucosal ischemia, ulceration, or stenosis, even during prolonged use (up to 8 hours).
• Precise Positioning: Clear depth markings (in cm) on the main tube and bronchial alignment indicators (e.g., "L" for left bronchus, "R" for right bronchus) guide accurate placement, verified via fiberoptic bronchoscopy. Ensures the cuff is positioned at the bronchial orifice for optimal isolation.

 

 

• Universal Compatibility: 15mm ISO standard connector fits all ventilators, anesthesia machines, and breathing circuits. Double-lumen models include a Y-adapter for independent control of left/right lung ventilation, supporting variable ventilation modes (e.g., pressure-controlled ventilation, volume-controlled ventilation).
• Superior Biocompatibility: Medical-grade PVC/silicone materials meet ISO 10993 biocompatibility standards, with no cytotoxicity, sensitization, or mucosal irritation. Hypoallergenic properties make it suitable for patients with sensitive airways.
• Easy to Use: Pre-sterilized and ready for immediate insertion; the inflation valve features a one-way design to maintain cuff pressure, with a pressure gauge (optional) for real-time monitoring. Flexible tube design accommodates patient positioning during surgery (e.g., lateral decubitus).

Certifications: Fully complies with ISO 13485 medical device quality management system standards, CE medical device certification, and NMPA registration requirements. Each production batch undergoes rigorous quality testing:

Cuff Seal Integrity Test: Verifies no air leakage under simulated clinical pressure (30 cmH₂O) and airflow (50 L/min) to ensure reliable lung isolation.

Cuff Pressure Retention Test: Ensures the cuff maintains stable pressure for ≥8 hours without deflation; the one-way inflation valve prevents air backflow.

Tube Patency Test: Confirms unobstructed airflow through the lumen (single-lumen) or both lumens (double-lumen) under simulated ventilation conditions.

Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and mucosal irritation tests on all patient-contact materials, complying with ISO 10993.

Sterility Validation: 100% EO sterilization with biological indicator testing (Bacillus atrophaeus) to confirm no viable microorganisms.

Dimensional Accuracy Test: Validates tube length, outer diameter (Fr size), cuff dimensions, and depth marking precision.

Structural Stability Test: Simulates insertion, positioning, and surgical manipulation to ensure no tube kinking, cuff rupture, or valve failure.

Each product is marked with a unique batch number, Fr size, and expiration date for full traceability of production, sterilization, and distribution. A detailed Instruction for Use (IFU) is provided, including insertion steps, cuff pressure guidelines, positioning verification methods, and contraindications.

Packing: Individual units are sealed in EO-sterilized paper-plastic composite packaging (waterproof, dustproof, and tear-resistant) with an inflation syringe, pressure reference card, and user manual. Double-lumen models include a sterile Y-adapter. Bulk transport in sturdy corrugated cartons with anti-crush foam inserts to protect packaging integrity and prevent product damage.

Storage: Store in a clean, dry, well-ventilated environment with a temperature of -10℃~40℃ and relative humidity ≤80%. Avoid direct sunlight, high temperature, high humidity, and contact with sharp objects or corrosive substances (e.g., acids, alkalis). Keep packages sealed until immediate use; do not use if the packaging is torn, damaged, or the sterile indicator shows invalidation. Stack cartons no more than 10 layers to prevent crushing.

Handling: Single-use only-discard immediately after use; do not reuse, reprocess, or sterilize to avoid cross-infection and material degradation. Inspect the package for damage and the product for defects (e.g., tube kinking, cuff tears, valve blockage) before use; do not use if any abnormalities are found. Use fiberoptic bronchoscopy to verify positioning after insertion to ensure effective lung isolation.

Transportation: Transport in accordance with national and international medical device transportation regulations, avoiding violent collision, jolting, rain, or moisture. Use insulated vehicles for transportation in extreme temperature environments (below -10℃ or above 40℃) to ensure product integrity. The transportation process shall be recorded, including departure date, destination, transportation conditions, and receiver information, for full traceability.

Zhejiang Mediunion Healthcare Group Co. Ltd. (a branch of Evergrand Healthcare Group, founded in 2014) is located in Ningbo City, Zhejiang Province - enjoying an excellent location and convenient transportation. Our business covers medical device manufacturing & sales, plus investments in nursing homes, dental clinics, specialist hospitals and medical care services. Our products are sold worldwide, and we've won global consumer recognition with high-quality goods and comprehensive after-sales service.

Diversified Product Portfolio

Our product range includes disposable medical consumables, medical equipment and non-woven products (e.g. dental supplies, respiratory care items). This diverse lineup caters to the needs of medical institutions, clinics and other clients.

Reliable Supply & Collaboration

We have rich industry experience and partner with over 600 factories. These partners are equipped with advanced production equipment and skilled frontline staff, enabling us to produce customized products/components as per specific requests.

Strict Quality Assurance

We prioritize innovation & quality, backed by the ISO 13485:2016 quality management system. Strict control runs through raw material procurement, mass production, process management and finished product release. Our professional services (production control, order follow-up, delivery) also set us apart.

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