A non-rebreathing oxygen mask is a specialized oxygen therapy device designed to deliver high-concentration oxygen (80%-100%) to patients with severe hypoxemia or acute respiratory distress. Key features include a latex-free, transparent mask body, an attached reservoir bag (typically 500-1000mL), and integrated one-way valves-all working together to prevent re-inhalation of exhaled carbon dioxide and ensure maximum oxygen delivery. It is widely used in emergency settings, intensive care units (ICUs), and post-operative recovery for patients requiring urgent, high-level oxygen support.
Crafted from soft, latex-free medical-grade PVC, the mask minimizes skin irritation and allergy risks, making it safe for sensitive patients. The transparent design allows healthcare providers to monitor lip color (a critical indicator of oxygenation) and facial expressions in real time. The reservoir bag stores oxygen between breaths, ensuring a continuous supply of concentrated oxygen; one-way valves on the mask edges and bag inlet prevent exhaled gas from re-entering the bag or mask, while also blocking room air from diluting the oxygen. An adjustable elastic head strap ensures a snug, leak-proof fit-vital for maintaining high oxygen concentrations-without causing excessive facial pressure. Compatible with standard oxygen sources and supply tubing, the mask requires minimal setup: simply pre-inflate the reservoir bag with oxygen before application, then adjust the flow rate to 10-15 L/min for optimal performance. Each unit undergoes rigorous quality testing, including valve functionality checks, leakage assessments, and biocompatibility verification, complying with ISO 13485, CE, and NMPA standards for reliable emergency and critical care use.
Product Specification
|
Item |
Description |
|
Application |
High-concentration oxygen therapy for severe hypoxemia |
|
Type |
Non-rebreathing design |
|
Material |
Latex-free medical-grade PVC |
|
Oxygen Concentration |
80%-100% |
|
Reservoir Bag Capacity |
500mL (pediatric), 1000mL (adult) |
|
One-Way Valves |
2-3 valves |
|
Applicable Population |
Adults, pediatric patients |
|
Connection |
Compatible with standard oxygen supply tubing |
|
Fixing Method |
Adjustable elastic head strap |
|
Sterility |
EO-sterilized |
|
Shelf Life |
3 years |
Product Properties
- High Oxygen Concentration: Delivers 80%-100% oxygen-higher than simple or Venturi masks-for severe hypoxemia relief.
- Rebreathing Prevention: One-way valves block exhaled CO₂ re-inhalation and room air dilution, ensuring pure oxygen delivery.
.
- Reservoir Bag Design: Stores oxygen to maintain consistent supply between breaths, avoiding oxygen starvation during inhalation.
- Latex-Free Safety: Eliminates latex allergy risks, safe for patients with latex sensitivities.
- Transparent & Comfortable: Transparent mask enables oxygenation monitoring; soft PVC reduces facial irritation during extended wear
Application
Emergency Care:
Ambulances, ERs, and trauma settings for patients with acute severe hypoxemia (e.g., cardiac arrest, severe pneumonia).
01
Intensive Care:
ICUs for critically ill patients (e.g., respiratory failure, sepsis, ARDS) before mechanical ventilation.
02
Post-Operative Recovery:
For patients with post-surgical oxygen desaturation unresponsive to lower-concentration masks.
03
Pediatric Critical Care:
Size-adapted masks with smaller reservoir bags for infants/children with severe respiratory distress (e.g., bronchiolitis, croup exacerbation).
04
Trauma Support:
For patients with chest injuries, pulmonary contusions, or airway obstruction causing severe hypoxemia.
05
Physical Properties
|
Item |
Specification |
|
Operating Temperature |
5℃~40℃ |
|
Material Hardness |
Shore A 30-35 |
|
Mask Weight |
Adult: 20-25g; Pediatric: 12-18g |
|
Reservoir Bag Material |
Latex-free PVC |
|
Head Strap Length |
Adjustable |
|
Leakage Rate |
≤5% |
|
Valve Opening Pressure |
1-2 cmH₂O |
QA&QC
- Certifications: Complies with ISO 13485, CE, and NMPA medical device standards.
- Batch Testing: Each batch undergoes valve functionality testing (to confirm one-way flow), reservoir bag inflation pressure checks, oxygen leakage assessments, and latex-free material verification.
- Quality Traceability: Unique batch number for full production and distribution tracking.
- Safety Documentation: Provides detailed Instruction for Use (IFU) and Material Safety Data Sheet (MSDS).
Packing,Storage,Handling and Transportation
Packing: Individual EO-sterilized paper-plastic composite packaging (includes mask, reservoir bag, and head strap); bulk transport in sturdy corrugated cartons.
Storage: Store in a clean, dry, well-ventilated environment (temperature 5℃~40℃, relative humidity ≤80%). Avoid direct sunlight, high heat, or sharp objects that may damage the reservoir bag or valves.
Handling: For single-patient use only-do not reuse or share to prevent cross-infection. Pre-inflate the reservoir bag before application; check valves for sticking or damage. Discard if the mask/valves show signs of wear or contamination.
Transportation: Transport in accordance with medical device regulations. Protect from violent collision, rain, or moisture to preserve valve functionality and reservoir bag 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:Can you cooperate with official sampling inspections, unannounced inspections, or on-site audits?
A:Yes, we fully cooperate with official sampling inspections, unannounced inspections, and on-site audits by regulatory authorities or customer-appointed third parties. We provide unrestricted access to our factory, production facilities, quality control laboratories, and all relevant documents (e.g., batch records, test reports, SOPs). Our team will assign a dedicated coordinator to assist with the inspection process and ensure timely provision of required information.
Q:Do you have a change control process for product changes (raw materials / processes / packaging)?
A: Yes, we have a strict change control process in compliance with ISO 13485 and MDR requirements. Any changes to raw materials, production processes, or packaging must go through the following steps:
Submit a change request detailing the reason for the change, scope, and potential impact;
Conduct risk assessment and technical verification (e.g., quality testing, compliance review);
Obtain approval from the quality department and relevant regulatory authorities (if required);
Notify customers of the change (at least 30 days in advance for critical changes) and obtain their consent if necessary;
Implement the change and update relevant documents (SOPs, labels, technical files);
Monitor the effectiveness of the change through post-implementation reviews.
Q:Do you have dual suppliers or alternative options for key raw materials?
A: Yes, we maintain dual suppliers or multiple alternative options for all key raw materials. This ensures that if one supplier experiences supply disruptions (e.g., raw material shortages, quality issues, or geopolitical factors), we can quickly switch to an alternative supplier without affecting production continuity. All alternative suppliers undergo strict qualification audits and sample testing to ensure their raw materials meet our quality and compliance standards.
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