A Venturi mask is a specialized oxygen therapy device engineered for precision oxygen delivery, designed to provide controlled and predictable oxygen concentrations to patients who require strict regulation of oxygen intake-such as those with chronic obstructive pulmonary disease (COPD), asthma, or other conditions where excessive oxygen may cause harm. Crafted from lightweight, transparent medical-grade PVC, it leverages the Venturi effect (air entrainment through calibrated ports) to mix oxygen with room air at fixed ratios, ensuring consistent oxygen concentrations regardless of the patient's respiratory rate or tidal volume.
At the core of its design are interchangeable entrainment adapters (ports)-each marked with a specific oxygen concentration (e.g., 24%, 28%, 35%, 40%, 50%). By swapping these adapters, healthcare providers can quickly adjust the oxygen-air mixture to match the patient's clinical needs, eliminating the guesswork associated with simpler masks. The transparent mask body allows for real-time monitoring of the patient's lip color, facial expressions, and mask fit, while the soft, contoured edge reduces skin irritation during extended wear. An adjustable elastic head strap ensures a secure, leak-proof seal (critical for maintaining precise concentration) without causing facial discomfort. Compatible with standard oxygen supply tubing and sources, the mask requires minimal setup: attach the desired entrainment adapter, connect to oxygen, and set the flow rate to the value specified for the adapter (typically 4-12 L/min). Each unit undergoes rigorous quality testing-including concentration accuracy verification, leakage checks, and adapter fit validation-complying with ISO 13485, CE, and NMPA standards for reliable use in hospitals, clinics, and long-term care facilities.
Product Specification
|
Item |
Description |
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Application |
Controlled oxygen therapy for patients needing precise oxygen concentrations |
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Core Mechanism |
Venturi effect |
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Material |
Lightweight, transparent medical-grade PVC |
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Adjustable Oxygen Concentrations |
24%, 28%, 35%, 40%, 50% |
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Recommended Flow Rates |
4-12 L/min |
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Applicable Population |
Adults, pediatric patients |
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Connection |
Compatible with standard oxygen supply tubing |
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Fixing Method |
Adjustable elastic head strap |
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Sterility |
EO-sterilized / Non-sterile |
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Shelf Life |
3 years |
Product Properties
- Precision Concentration Control: Interchangeable entrainment ports deliver fixed oxygen concentrations (±2% accuracy), avoiding over-oxygenation or under-oxygenation.
- Flow-Independent Performance: Maintains consistent oxygen-air mixture regardless of patient respiratory rate or tidal volume-ideal for unstable breathers.
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Transparent Design: Enables easy monitoring of patient oxygenation status (e.g., lip color) and detection of mask slippage or blockages.
Latex-Free Safety: Eliminates latex allergy risks, suitable for patients with sensitive skin or latex sensitivities.
Easy Adjustment: Quick-swap entrainment adapters allow healthcare providers to modify concentrations without changing the entire mask, saving time in clinical settings.
Application
COPD Management:
Prevents oxygen-induced hypercapnia by delivering precise, low-to-moderate oxygen concentrations (e.g., 24%-28%).
01
Asthma Exacerbations:
Provides controlled oxygen support to avoid respiratory depression while improving hypoxemia.
02
Post-Operative Recovery:
Delivers predictable oxygen levels for patients transitioning from mechanical ventilation to spontaneous breathing.
03
Pediatric Respiratory Care:
Size-adapted masks and small-volume entrainment adapters ensure safe, precise oxygen delivery for children with delicate respiratory systems.
04
Critical Care Transitions:
Used in ICUs or step-down units for patients requiring gradual adjustment of oxygen support before discharge.
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Physical Properties
|
Item |
Specification |
|
Operating Temperature |
5℃~40℃ |
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Material Hardness |
Shore A 30-35 |
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Mask Weight |
Adult: 18-22g; Pediatric: 10-15g |
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Entrainment Adapter Size |
Adult: 10-12mm ; Pediatric: 8-10mm |
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Head Strap Length |
Adjustable |
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Leakage Rate |
≤5% |
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Transparency |
≥90% light transmittance |
QA&QC
1. Certifications: Complies with ISO 13485, CE (EU MDR), and NMPA medical device standards.
Batch Testing: Each production batch undergoes:
2.1. Concentration accuracy testing (verifies adapter-specific oxygen levels via gas analysis);
2.2. Leakage testing (ensures no air dilution outside of entrainment ports);
2.3. Adapter fit validation (confirms secure attachment to mask body);
2.4. Biocompatibility assessments (cytotoxicity, sensitization) for PVC material.
3. Quality Traceability: Unique batch number assigned to each unit, enabling full tracking from production to distribution.
4. Safety Documentation: Provides detailed Instruction for Use (IFU) (including adapter-flow rate charts) and Material Safety Data Sheet (MSDS).
Packing,Storage,Handling and Transportation
Packing: Individual blister packaging (includes mask body + set of 5 entrainment adapters); sterile versions use EO-sterilized paper-plastic composite packaging. Bulk transport in sturdy corrugated cartons with anti-crush dividers.
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 (which may degrade PVC). Keep entrainment adapters in a sealed bag to prevent loss or contamination.
Handling: For single-patient use (sterile) or repeated use with the same patient (non-sterile). Clean non-sterile masks with mild detergent and warm water after use; avoid harsh chemicals that may damage the entrainment ports. Inspect adapters for cracks or blockages before each use.
Transportation: Transport in accordance with medical device regulations. Protect from violent collision, rain, or moisture to preserve mask integrity and adapter calibration.
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: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.
Q:How do you manage raw material price fluctuations or shortages?
A:We manage raw material price fluctuations and shortages through the following strategies:
Signing long-term supply agreements with core raw material suppliers to lock in prices and ensure stable supply;
Maintaining safety stock of key raw materials (covering 1-2 months of production demand);
Monitoring global raw material market trends and establishing early warning mechanisms for potential shortages;
Working with suppliers to develop alternative raw materials (with equivalent quality and compliance) for high-risk materials;
Absorbing moderate price fluctuations through internal efficiency improvements to minimize the impact on customer pricing.
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