A tracheostomy mask is a specialized medical device designed for oxygen delivery and airway care in patients with a tracheostomy tube. Crafted from soft, skin-friendly medical-grade materials, it features a contoured, secure-fitting design that fits snugly over the tracheostomy stoma-delivering supplemental oxygen directly to the patient's airway while providing gentle humidification to prevent mucosal dryness. It is an essential tool for tracheostomy care in hospitals, long-term care facilities, and home care settings, catering to patients requiring continuous or intermittent oxygen support.
The mask's soft, flexible construction minimizes pressure on the surrounding skin and stoma site, reducing irritation and discomfort during extended wear. A built-in humidification port allows connection to a sterile water source or humidifier, ensuring the delivered oxygen is moistened to protect the delicate tracheal mucosa from dryness and damage. The secure-fitting design-enhanced by an adjustable elastic head strap-prevents oxygen leakage and maintains consistent delivery, while the transparent mask body enables healthcare providers to monitor the stoma site for signs of inflammation, secretion buildup, or dislodgement. Compatible with standard oxygen sources and tracheostomy tubes of various sizes, it requires simple setup: attach to oxygen supply tubing, connect a humidifier (if needed), adjust the flow rate, and secure the mask over the stoma. Each unit undergoes strict quality testing, including leakage checks, biocompatibility assessments, and fit validation, complying with ISO 13485, CE, and NMPA standards for safe and reliable tracheostomy care.
Product Specification
|
Item |
Description |
|
Application |
Oxygen delivery + humidification for patients with tracheostomy tubes |
|
Core Function |
Direct oxygen supply to tracheal airway; prevents mucosal dryness via humidification |
|
Material |
Soft medical-grade PVC |
|
Key Features |
Contoured design, secure fit, built-in humidification port, adjustable head strap |
|
Compatible Tracheostomy Tube Sizes |
Fits adult/pediatric tracheostomy tubes |
|
Oxygen Flow Rate |
2-10 L/min |
|
Humidification Compatibility |
Works with standard heated/cold water humidifiers |
|
Fixing Method |
Adjustable elastic head strap |
|
Sterility |
EO-sterilized |
|
Shelf Life |
3 years |
Product Properties

- Direct Airway Delivery: Fits over the tracheostomy stoma to deliver oxygen directly to the trachea, ensuring efficient oxygenation.
- Soft & Comfortable: Skin-friendly material reduces pressure on the stoma site and surrounding skin, minimizing irritation.
- Built-In Humidification: Dedicated port for humidifier connection, preventing tracheal mucosal dryness and damage.
- Secure Fit: Adjustable head strap ensures a leak-proof seal, maintaining consistent oxygen delivery without slippage.
- Transparent Design: Allows visual monitoring of the stoma site for complications (e.g., redness, secretion buildup).
- Latex-Free Safety: Eliminates latex allergy risks, suitable for sensitive patients.

Application
Hospital Care:
Used in ICUs, general wards, and step-down units for post-operative tracheostomy patients or those with chronic respiratory failure.
01
Long-Term Care Facilities:
Supports daily oxygen and humidification needs for residents with permanent tracheostomies.
02
Home Care:
Enables safe, convenient oxygen therapy for patients transitioning from hospital to home with a tracheostomy.
03
Pediatric Tracheostomy Care:
Size-adapted masks for children with tracheostomies, ensuring gentle fit and age-appropriate oxygen delivery.
04
Acute Respiratory Support:
Provides humidified oxygen for patients with tracheostomies recovering from pneumonia, COPD exacerbations, or airway injuries.
05
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
5℃~40℃ |
|
Material Hardness |
Shore A 25-30 |
|
Mask Weight |
Adult: 20-25g; Pediatric: 12-18g |
|
Humidification Port Diameter |
10mm |
|
Head Strap Length |
Adjustable |
|
Leakage Rate |
≤5% |
|
Transparency |
≥85% light transmittance |
QA&QC
Certifications: Complies with ISO 13485, CE (EU MDR), and NMPA medical device standards. Each production batch undergoes leakage testing (ensures no oxygen/humidity leakage), biocompatibility assessments (cytotoxicity, sensitization) for skin contact materials, fit validation (confirms compatibility with common tracheostomy tube sizes), and humidification port functionality testing (verifies secure connection to humidifiers). Unique batch number is assigned for full production and distribution traceability, and detailed Instruction for Use (IFU) and Material Safety Data Sheet (MSDS) are provided.

Packing,Storage,Handling and Transportation
Packing: Individual EO-sterilized paper-plastic composite packaging (includes mask body and adjustable head strap); bulk transport in sturdy corrugated cartons with anti-crush protection.
Storage: Store in a clean, dry, well-ventilated environment (temperature 5℃~40℃, relative humidity ≤80%). Avoid direct sunlight, high heat, or contact with corrosive substances. Keep packaging intact until use.
Handling: For single-patient use only-do not reuse or share to prevent cross-infection. Inspect the mask for cracks, tears, or material degradation before use. Ensure the humidification port is securely connected to avoid water leakage into the stoma.
Transportation: Transport in accordance with medical device regulations. Protect from violent collision, rain, or moisture to preserve product sterility and structural integrity.
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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