The Endotracheal Tube Holder is a specialized medical device designed for secure fixation of endotracheal tubes (ETTs) in patients requiring mechanical ventilation or airway support. It serves as a critical tool to prevent tube displacement, accidental extubation, or excessive movement that could cause airway mucosal trauma, pressure ulcers, or ventilation disruption. Crafted from medical-grade, skin-friendly materials, the holder features an ergonomic design with adjustable straps, pressure-dispersing cushions, and anti-slip components, ensuring stable fixation while maximizing patient comfort. Suitable for adults, pediatric patients, and infants, it is widely used in ICUs, operating rooms, emergency departments, and during patient transfer-indispensable for maintaining airway patency in critically ill or anesthetized patients.
Engineered to address clinical pain points of traditional fixation methods (e.g., tape, sutures), the holder integrates multiple user-centric features: soft, breathable cushions reduce pressure on facial skin and nasal bridge; adjustable Velcro straps allow precise tension control to avoid excessive compression; anti-slip silicone strips on the tube contact surface prevent ETT rotation or sliding; and a lightweight, low-profile structure minimizes interference with patient care (e.g., facial cleaning, imaging exams). No complex tools are required for installation-simply position the holder, secure the straps around the patient's head, and lock the tube in place. Each unit undergoes strict quality validation, complying with ISO 13485, CE, and NMPA medical device standards to ensure biocompatibility, fixation reliability, and long-term structural stability.
Product Specification
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Item |
Description |
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Application |
Secure fixation of endotracheal tubes (ETTs); prevents tube displacement/accidental extubation; reduces airway mucosal trauma and facial pressure ulcers; compatible with mechanical ventilation |
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Core Components |
Ergonomic head strap (forehead/occipital), pressure-dispersing silicone cushion, anti-slip tube clamp, adjustable Velcro fasteners, size-adaptive buckles |
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Material |
Head strap: Medical-grade breathable non-woven fabric; Cushion: Medical-grade liquid silicone; Clamp/Straps: Hypoallergenic polyester + Velcro; Buckles: ABS |
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Compatible Populations |
Adults (Size L/XL), pediatric patients (Size M/S), infants (Size XS); fits ETT sizes: 3.0-10.0Fr |
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Key Safety Features |
Anti-slip tube fixation, pressure-dispersing design, adjustable tension, hypoallergenic materials, no latex components |
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Dimensions |
Adult (L): Head circumference 55-65cm; Pediatric (M): 45-55cm; Infant (XS): 35-45cm |
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Sterility |
EO-sterilized (single-use only, non-reusable) |
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Shelf Life |
3 years (unopened, properly stored in sterile packaging) |
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Accessory |
Sterile paper-plastic composite packaging, size reference chart, user instruction leaflet |
Product Properties
- Reliable Anti-Displacement Fixation: Anti-slip silicone clamp with textured inner surface grips the ETT tightly, preventing rotation, sliding, or accidental extubation even during patient movement (e.g., turning, transfer). Fixation strength ≥15N, ensuring tube stability under clinical conditions.
- Pressure-Dispersing Comfort: Thickened silicone cushions (3-5mm) on the forehead and occipital contact areas distribute pressure evenly, reducing facial skin stress to ≤30 mmHg-effectively preventing nasal bridge pressure ulcers in long-term ventilated patients.
- Hypoallergenic & Skin-Friendly: All materials meet ISO 10993 biocompatibility standards, with no latex, cytotoxicity, or skin sensitization. Breathable non-woven fabric enhances air circulation, minimizing moisture accumulation and skin irritation.
- Easy Adjustment & Operation: Adjustable Velcro straps allow on-the-go tension modification without removing the holder, adapting to patient head size changes (e.g., edema) and ensuring optimal fixation. Tool-free installation takes ≤60 seconds, improving clinical workflow efficiency.
- Universal Compatibility: Size-adaptive design fits all ETT diameters (3.0-10.0Fr) and tracheostomy tubes; multiple size options (XS-XL) accommodate adults, children, and infants, matching diverse anatomical structures. Low-profile structure avoids interference with facial masks, oxygen cannulas, or monitoring devices.
Application Scenarios
Thoracic Surgery: Operating rooms for lobectomy, pneumonectomy, segmentectomy, esophageal cancer surgery, and thoracoscopic procedures, where lung isolation is required to facilitate surgical manipulation and protect the healthy lung.
Critical Care & Emergency Rescue: ICUs and emergency departments for patients with massive hemoptysis, lung abscess, or unilateral lung injury, isolating the affected lung to prevent contamination and maintain adequate ventilation in the healthy lung.
Trauma Management: Pre-hospital and in-hospital rescue for thoracic trauma patients (e.g., penetrating chest injury, lung contusion) requiring selective lung ventilation to stabilize respiratory function.
Pediatric Thoracic Procedures: Pediatric operating rooms for adolescents and children undergoing lung surgery (e.g., congenital lung malformation resection), with size-specific single-lumen or small double-lumen tubes tailored to pediatric airway anatomy.
Lung Transplantation: Specialized transplant centers for donor lung preparation and recipient lung isolation during transplantation surgery, ensuring optimal ventilation and organ protection.
Interventional Pulmonology: For procedures such as bronchial stenting or laser ablation, isolating the target bronchus to reduce procedural risks and improve therapeutic accuracy.
QA&QC
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:
Fixation Strength Test: Verifies the holder can withstand ≥15N pull force without tube slippage or strap breakage.
Pressure Distribution Test: Confirms facial contact pressure ≤30 mmHg to prevent pressure ulcers.
Biocompatibility Assessment: Conducts cytotoxicity, skin sensitization, and irritation tests on all 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 head circumference range, strap length, and cushion thickness (tolerance ±0.5cm/mm).
Durability Test: Simulates 100+ adjustment cycles to ensure Velcro adhesion and strap structural stability.
Each product is marked with a unique batch number, size, and expiration date for full traceability of production, sterilization, and distribution. A detailed Instruction for Use (IFU) is provided, including installation steps, tension adjustment guidelines, and contraindications.
Packing, Storage, Handling and Transportation
Packing: Individual units are sealed in EO-sterilized paper-plastic composite packaging (waterproof, dustproof, and tear-resistant) with a size reference chart and user manual. Bulk transport in sturdy corrugated cartons with anti-crush foam inserts to protect packaging integrity.
Storage: Store in a clean, dry, well-ventilated environment with a temperature of -5℃~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 12 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., strap tearing, cushion deformation) before use; do not use if any abnormalities are found. Adjust tension regularly during use to maintain comfort and fixation effectiveness.
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 -5℃ 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.
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 samples from mass production or lab batches?
A:All samples provided are from mass production batches, not lab batches. This ensures that the sample quality, performance, and specifications are fully consistent with the bulk products you will receive, allowing you to accurately evaluate the product's actual use effect and compliance.
Q:Do you support trial orders for new customers?
A:Yes, we actively support trial orders for new customers.With preferential pricing to help you minimize initial investment risks. We also provide full technical support and after-sales service during the trial period to ensure a smooth cooperation experience.
Q:How long does sample preparation take?
A:The sample preparation time depends on whether the product is standard or customized:
For standard products: Sample preparation takes 5-7 working days;
For customized products (e.g., custom specifications, labeling, or packaging): Sample preparation takes 15-30 working days. If urgent samples are required, we can expedite the process to 15-25 working days upon request.
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