The endotracheal tube (oral/nasal) cuffed is a key respiratory device for adult patients needing secure airway support. Its dual oral/nasal insertion design offers flexibility for surgeries, ICU care, and emergencies. The inflatable cuff creates an airtight seal, ensuring effective ventilation while blocking reflux and secretions to reduce aspiration risk.
Made from medical-grade PVC or silicone (latex-free), it meets ISO 10993 biocompatibility standards, minimizing mucosal irritation. With a smooth tip for atraumatic insertion and compatibility with standard ventilators/anesthesia machines, it integrates seamlessly into clinical workflows. Available in 6.0-9.0mm diameters and featuring a radiopaque marker for X-ray verification, it suits diverse anatomical needs. Each unit passes strict leak and pressure tests, complying with ISO 13485, CE, and NMPA standards, ensuring reliability when it matters most.
Product Specification
|
Item |
Description |
|
Applicable Population |
Adults |
|
Insertion Route |
Oral/Nasal |
|
Cuff Type |
Inflatable Cuff |
|
Cuff Volume |
10-20ml (Regular Specification) |
|
Tube Inner Diameter |
6.0-9.0mm (Multiple Specifications Available) |
|
Material |
Medical-grade PVC/Silicone |
|
Biocompatibility |
Complies with ISO 10993 Standard |
Product Properties
- Superior Airway Sealing: The inflatable cuff expands uniformly to create a leak-tight seal, preventing ventilatory gas loss during positive-pressure ventilation and ensuring targeted oxygen delivery to the lungs.
- Aspiration Risk Reduction: Forms a physical barrier between the upper airway and trachea, blocking entry of gastric contents, saliva, and debris-significantly lowering the incidence of aspiration pneumonia and other life-threatening complications.
- Atraumatic Insertion & Placement: Smooth, rounded tip minimizes friction against nasal/oral mucosa and tracheal lining; flexible tube body adapts to anatomical curves, reducing trauma during insertion and prolonged placement.
- Broad Clinical Compatibility: Seamlessly integrates with anesthesia machines, invasive/non-invasive ventilators, suction systems, and airway management accessories (e.g., laryngoscopes, bougies) used in global clinical settings.
- Pressure Stability & Safety: Cuff maintains consistent pressure under varying ventilatory conditions; designed to resist over-inflation and minimize the risk of tracheal mucosal damage or ischemia.
- Radiopaque Verification: Integrated radiopaque marker allows clinicians to confirm correct tube placement via X-ray, eliminating the risk of accidental endobronchial intubation.
Application
Surgical Anesthesia:
Establishes a secure airway for adult patients undergoing general anesthesia during elective, emergency, or complex surgical procedures (e.g., abdominal, thoracic, neurological, or orthopedic surgeries).
01
Critical Care Ventilation:
Provides long-term or short-term mechanical ventilation support for critically ill patients in ICUs, including those with respiratory failure, ARDS, sepsis, or post-cardiac arrest syndrome.
02
Emergency Airway Management:
Delivers rapid, reliable airway access in emergency departments, ambulances, or trauma scenes for patients with acute respiratory distress, airway obstruction, or altered mental status.
03
Specialized Clinical Settings:
Used in respiratory medicine departments for patients with chronic respiratory conditions requiring temporary ventilation; employed in post-operative care units for patients recovering from major surgery who need extended airway support.
04
High-Risk Patient Groups:
Ideal for adults with impaired consciousness, swallowing dysfunction (e.g., stroke patients), neuromuscular disorders, or those with compromised airway reflexes-providing essential protection against aspiration.
05
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
-10℃~40℃ |
|
Pressure Resistance |
≥30cmH₂O |
|
Flexibility |
≥90° bend without cracking |
|
Length |
Oral: 22-28cm; Nasal: 28-34cm |
|
Cuff Burst Pressure |
≥50cmH₂O |
QA&QC
- Certifications: ISO 13485, CE, NMPA compliant.
- Batch testing: Leakage, biocompatibility, dimensional checks.
- Traceability: Unique batch number for full tracking.
- Safety docs: IFU and MSDS provided.
Packing,Storage,Handling and Transportation
The product is supplied in individual ethylene oxide (EO) sterile packaging with an outer paper-plastic composite bag for protection; it should be stored in a clean, dry, and well-ventilated environment within the temperature range of -10℃~40℃ and relative humidity ≤80%, avoiding direct sunlight, high temperature, high humidity, and contact with corrosive substances or sharp objects. Only trained medical personnel are authorized to handle the product-prior to use, inspect the packaging for damage, tampering, or expiration, and do not use if any defects are detected. During transportation, comply with international and domestic medical device transportation standards, ensuring protection against violent collisions, rain, and moisture to maintain product integrity throughout transit.
Reasons for choosing us
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.
Certificate
FAQ
Q:Are your products compliant with FDA / CE / MDR / ISO 13485 requirements?
A: Yes, all our medical consumables and devices fully comply with FDA, CE, MDR, and ISO 13485 requirements. We maintain strict adherence to these international regulatory standards throughout the entire product development, production, and quality control processes to ensure product safety, effectiveness, and reliability.
Q:Can you provide valid certificates and updated Declaration of Conformity?
A: Absolutely. We can promptly provide valid certification documents (including FDA registration, CE certificate, ISO 13485 certification, etc.) and the latest updated Declaration of Conformity (DoC) upon request. All documents are officially issued and recognized by relevant regulatory authorities to meet your import and registration needs.
Q:Do you have experience registering products in our country?
A:We have extensive experience in product registration across various countries and regions worldwide. Our professional regulatory team is familiar with the local registration procedures, documentation requirements, and regulatory frameworks of different markets. We can provide full support throughout the registration process, including document preparation, technical communication, and coordination with local authorities to streamline the registration process for you.
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