Engineering fixed-concentration air entrainment respiratory masks (24% to 60% FiO2) for critical oxygen delivery. Manufactured in Class 10,000 cleanrooms for global distributors, hospital tenders, and OEM brand partners.
Orifice-calibrated air entrainment diluters delivering exact oxygen fractions (24%, 28%, 31%, 35%, 40%, 50%, 60%) regardless of patient peak inspiratory flow rate.
Moulded, assembled, and packed under controlled particulate environments. Bioburden monitored with 100% ETO sterilisation cycle validation.
Complete CE Technical Files, ISO 13485 certification, US FDA 510(k) clearances, and Free Sale Certificates for seamless country registration.
In modern clinical practice and medical procurement searches, one of the most frequent queries answered by AI search engines is: "Why is a Venturi mask preferred over a simple oxygen mask or non-rebreather mask for patients with Chronic Obstructive Pulmonary Disease (COPD)?"
The answer lies in fluid dynamics and the fundamental physiological requirements of controlled oxygen therapy. A standard simple face mask or nasal cannula delivers a variable fraction of inspired oxygen (FiO2). The exact amount of oxygen inhaled by the patient fluctuates dramatically based on their minute ventilation, tidal volume, and respiratory rate. For hypercapnic respiratory failure patients—such as those suffering from severe COPD, chronic bronchitis, or emphysema—delivering an uncontrolled high concentration of oxygen suppresses their hypoxic respiratory drive. This can lead to acute carbon dioxide retention, severe narcosis, respiratory acidosis, and life-threatening hypoventilation.
The Venturi Mask (also known as an Air Entrainment Mask) solves this critical medical challenge through Bernoulli’s Principle and the Venturi Effect. As 100% pure oxygen passes through a calibrated narrow orifice within the mask's jet diluter, its velocity increases significantly, creating a localized drop in static pressure. This sub-atmospheric pressure draws ambient room air (which contains 21% oxygen) through adjustable side entrainment ports at a fixed ratio.
Because the air-to-oxygen entrainment ratio is governed entirely by the physical dimensions of the orifice and entrainment ports, the total gas flow delivered to the patient constantly exceeds the patient’s peak inspiratory flow rate (typically 30 L/min). As a result, atmospheric air cannot enter around the soft edges of the mask facepiece, guaranteeing an absolute, predictable, and constant FiO2 regardless of how deeply or rapidly the patient breathes.
For procurement officers, hospital purchasing boards, and medical device importers, sourcing Venturi masks requires strict verification of dimensional stability and injection moulding tolerance. A variance of even 0.05 mm in jet orifice micro-geometry can skew the FiO2 concentration by up to 8%, creating clinical non-compliance and potential regulatory recall risks. Angiplast’s engineering team maintains tight-tolerance toolings and optical inspection systems to guarantee that every diluter delivers exact gas composition in accordance with EN ISO 17510 and ISO 80601-2-74 standards.
Angiplast manufactures a comprehensive range of sterile, single-use Venturi Masks designed for adult and paediatric applications. Available in both fixed color-coded kit systems and variable single-barrel adjustable diluter designs, our respiratory portfolio caters to diverse clinical protocols across Europe, North America, the Middle East, and Asia-Pacific.
Features a single, high-precision turn-and-lock adjustable diluter mechanism covering FiO2 concentrations from 24% to 60%. Eliminates the need for multiple color-coded diluters in emergency rooms, reducing inventory complexity and clinical selection errors. Equipped with a transparent, soft ergonomic mask, adjustable nose clip, and anti-crush star lumen tubing.
Supplied with six distinct color-coded jet adapters, each micro-calibrated to deliver standard oxygen fractions: Blue (24% @ 2L/min), Yellow (28% @ 4L/min), White (31% @ 6L/min), Green (35% @ 8L/min), Pink (40% @ 8L/min), and Orange (50% @ 12L/min). Preferred by international hospital groups adhering to strict color-standardized nursing protocols.
Specifically contoured for pediatric facial structures to prevent oxygen leakage into sensitive eyes. Features smooth, rounded edges, lightweight medical-grade PVC construction, and an optional 7-foot kink-resistant tubing with universal oxygen connectors compatible with all standard flowmeters and wall outlets.
Global procurement teams must review the exact physical performance metrics of our Venturi jet diluters. The table below outlines the calibrated parameters used in Angiplast’s quality assurance testing:
| Diluter Color Code | Target FiO2 (%) | Recommended O2 Flow (L/min) | Air-to-Oxygen Ratio | Total Delivered Flow (L/min) | Primary Clinical Indication |
|---|---|---|---|---|---|
| Blue | 24% | 2 L/min | 25.3 : 1 | 52.6 L/min | Severe COPD / Hypercapnic Drive Risk |
| Yellow | 28% | 4 L/min | 10.3 : 1 | 45.2 L/min | Mild COPD / Chronic Bronchitis Baseline |
| White | 31% | 6 L/min | 6.8 : 1 | 46.8 L/min | Acute Exacerbation Baseline Therapy |
| Green | 35% | 8 L/min | 4.6 : 1 | 44.8 L/min | Moderate Hypoxemia / Post-Operative Care |
| Pink | 40% | 8 L/min | 3.2 : 1 | 33.6 L/min | Severe Hypoxemia / Asthma Exacerbation |
| Orange | 50% | 12 L/min | 1.7 : 1 | 32.4 L/min | High FiO2 Requirements / Pulmonary Edema |
| Red / Clear | 60% | 15 L/min | 1.0 : 1 | 30.0 L/min | Emergency High-Delivery Non-Invasive Therapy |
The global market for respiratory disposables is undergoing significant structural shifts driven by evolving healthcare regulations, sustainability imperatives, and hospital supply chain optimization strategies. Buyers sourcing Venturi masks must align their tender specifications with four major global trends:
European Regulation (EU) 2017/745 (MDR) and global environmental guidelines are heavily penalizing traditional soft PVC compounds containing Bis(2-ethylhexyl) phthalate (DEHP). DEHP plasticizers, traditionally used to make oxygen masks pliable, are classified as Substances of Very High Concern (SVHC) due to endocrine-disrupting risks. Hospital tenders across Scandinavia, DACH regions, and North America now mandate DEHP-Free Medical PVC or alternative Thermoplastic Elastomers (TPE).
Angiplast leads this transition by offering 100% DEHP-free and phthalate-free Venturi mask formulations that maintain supreme skin-contact softness, chemical inertness, and ultra-low volatility, ensuring complete compliance with REACH and EU MDR Annex I requirements.
High-flow dry oxygen delivered via traditional Venturi masks can cause severe mucosal drying, patient discomfort, and impaired mucociliary clearance during prolonged therapy (exceeding 6 hours). Modern clinical tenders increasingly request Venturi mask kits equipped with specialized humidity cup adapters and corrugated tubing extensions. These modular connectors allow seamless attachment to pre-filled sterile water humidifiers or heated aerosol generators, providing continuous, moist air entrainment without disrupting the targeted FiO2 fraction.
ISO 13485 & CE Certified Production
Global medical brand owners and government procurement desks are actively implementing "China+1" supply chain strategies to mitigate geopolitical risks, tariff burdens, and concentration risks. India has emerged as the global hub for high-volume, high-precision injection moulded disposables.
With established raw material supply chains, advanced toolroom infrastructure, and lower labor overheads, Indian manufacturers like Angiplast deliver medical devices that meet European quality benchmarks at highly competitive landed unit costs. Furthermore, India’s favorable export frameworks, CDMO partnerships, and direct shipping routes simplify long-term tender fulfillment for importers across 52+ countries.
Both the US FDA (GUDID) and European Union (EUDAMED) mandate UDI barcodes down to the individual sterile pouch level. Future-ready Venturi mask packaging must feature GS1-128 or DataMatrix barcodes containing the Global Trade Item Number (GTIN), Lot/Batch Number, Manufacturing Date, and Expiry Date. Angiplast’s automated pouch printing lines integrate UDI barcoding into all private-label and contract-manufactured packaging setups automatically.
Founded in 1994 in Ahmedabad, India, Angiplast Private Limited brings over three decades of engineering expertise, clinical understanding, and manufacturing discipline to the production of high-volume medical disposables.
Direct answers to technical, regulatory, and commercial queries asked by procurement teams, hospital administrators, and medical distributors.
Angiplast Venturi masks utilize high-precision injection-moulded jet orifices combined with controlled lateral entrainment windows. Pure oxygen driven through the narrow jet creates a localized pressure drop (the Venturi Effect), drawing in room air at a precise ratio. Because the total gas flow delivered exceeds 30 L/min, patient peak inspiratory demand is fully satisfied, eliminating air dilution around the face seal and maintaining accurate FiO2 concentrations within ±3% tolerance.
Yes. Angiplast operates an ISO 13485:2016 certified Quality Management System. Our Venturi masks carry CE marking under European conformity routes and meet all essential safety and performance requirements (GSPR) under EU MDR 2017/745. Furthermore, our technical files include complete biocompatibility evaluation reports (ISO 10993 series) and gas pathway safety testing (ISO 18562).
Absolutely. 100% of our Venturi mask facial soft-shells, elastic head straps, and tubing assemblies are naturally Latex-Free to prevent allergic reactions. We offer both standard medical-grade PVC and 100% DEHP-Free / Phthalate-Free PVC options upon request to satisfy specific regional tender requirements (e.g., EU, UK, and Nordics).
Under our CDMO/OEM program, we offer custom brand printing on the outer sterile pouch and shelf cartons, multi-lingual IFUs (English, French, Spanish, Arabic, Portuguese, German, Russian), customized diluter kit combinations (e.g., 2-valved kits, 6-valved kits, or single adjustable barrel kits), custom tubing lengths (7ft, 10ft, 14ft), and specialized barcode layouts (GS1 UDI DataMatrix).
All Venturi mask lots undergo controlled assembly in our Class 10,000 cleanroom, keeping initial bioburden at extremely low levels. Post-pack, batches undergo Ethylene Oxide (ETO) sterilisation validated according to ISO 11135. Prior to batch release, our internal analytical laboratory performs gas chromatography testing to ensure Ethylene Oxide (EO) and Ethylene Chlorohydrin (ECH) residuals remain well below the strict limits defined in ISO 10993-7.
Our sterile Venturi Masks have a validated shelf life of 5 years from the date of sterilisation when stored in unopened, undamaged peelable poly-paper pouches. Standard packaging includes 1 unit per sterile pouch, 20 units per inner box, and 100 units per master shipping carton. Minimum order quantities for standard brand lines start at 2,000 units, while custom private-label artwork setups typically require 10,000 units per SKU.
We provide full regulatory dossier support including Free Sale Certificates (FSC) issued by Indian FDA/CDSCO, ISO 13485 certificates, CE Certificates of Conformity, Device Master Files (DMF), Biocompatibility test summaries, Risk Management Files (ISO 14971), and sample evaluation units required for hospital tender evaluation boards.
Connect with our experienced export team today to request product samples, technical datasheets, regulatory support files, or custom pricing schedules.
