Description
1. Product Overview
The Non Rebreathing Oxygen Mask with Reservoir Bag is a high-performance medical device engineered for delivering concentrated oxygen therapy in critical care and emergency medicine settings. Its primary industrial use spans pre-hospital emergency response, hospital emergency departments, and post-anesthesia recovery units where rapid, high‑FiO₂ delivery is clinically mandated. By combining a reservoir bag with a one‑way valve system that prevents exhaled CO₂ rebreathing, this mask achieves oxygen concentrations of 80–95% at flow rates of 10–15 L/min — a strategic advantage in reducing hypoxemia risk, improving patient outcomes, and lowering total cost of care through fewer desaturation events.
2. Key Specifications & Technical Characteristics
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Material composition: Medical‑grade, latex‑free PVC (mask body); non‑rebreathing valve assembly (polypropylene/ABS); reservoir bag (low‑permeability thermoplastic elastomer); elastic headstrap (nylon/spandex blend)
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Oxygen concentration delivered: 80–95% FiO₂ at 10–15 L/min with proper seal
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Physical characteristics: Clear, transparent mask body; 250–350 mL reservoir bag (adult size); color‑coded valve disk (white for inhalation / blue for exhalation)
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Sizes available: Adult, pediatric, infant (specific dimensions: adult mask volume ~180 mL; pediatric ~120 mL)
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Port connections: Standard 6 mm (M) tapered oxygen inlet, compatible with ISO 5356‑1 low‑pressure fittings
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Packaging options: Individually sealed sterile pouch (peel‑open) — 50 units/display box; 500 units/master carton
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Shelf life: 5 years from date of manufacture when stored in original packaging at 0–40°C, <80% relative humidity, away from direct sunlight and ozone
3. Core Industrial Applications
| Primary Industry | Operational Use Case | Performance Advantage |
|---|---|---|
| Emergency Medical Services (EMS) | Pre‑hospital trauma, cardiac arrest, respiratory distress, carbon monoxide poisoning | Reservoir bag maintains high oxygen reserve during patient transport; one‑way valves prevent dilution by room air — unlike simple masks that deliver only 35–60% FiO₂. |
| Hospital Emergency & Critical Care | Rapid sequence intubation preparation, post‑extubation support, severe pneumonia/ARDS (non‑intubated) | Delivers near‑anesthesia‑circuit oxygen levels without invasive airway management; reduces intubation rate for mild‑moderate hypoxemia. |
| Post‑Anesthesia Care Unit (PACU) | Emergence from general anesthesia, opioid‑induced respiratory depression | Low rebreathing CO₂ (<2%) prevents hypercapnia; transparent mask allows visual confirmation of condensation as breath indicator. |
| Long‑term care & transport ventilators (backup mode) | Interfacility transfer of oxygen‑dependent patients | Compatible with wall outlets, E‑cylinders, and portable concentrators (10–15 L/min range) — no proprietary connectors needed. |
Cost advantage: Up to 40% lower per‑use cost than venturi masks or non‑invasive ventilation interfaces, while achieving comparable oxygen delivery for spontaneously breathing patients.
4. Competitive Advantages
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Quality consistency: ISO 13485:2016 certified manufacturing; each valve disk flow‑tested for 0.5 cm H₂O cracking pressure — ensures <1% defect rate over 10M+ units shipped.
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Supply reliability: Dual‑sourcing of raw materials (USP Class VI PVC) and three geographically redundant production lines (Asia, Europe, Americas) — 98% on‑time in‑full delivery rate.
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Logistics capability: Stocked in regional hubs (NJ, Rotterdam, Shanghai) for 48‑hour dispatch to 140+ countries; expedited air freight available for emergency tenders.
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Price competitiveness: Direct‑to‑enterprise pricing (no distributor markup on bulk orders) — 15–20% below market average for equivalent CE/FDA listed products.
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Sustainability: Reservoir bag and mask body are DEHP‑free and fully incinerable; packaging uses 70% recycled cardboard with soy‑based inks.
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Technical support: Full IFU (Instructions For Use) in 12 languages; valve integrity troubleshooting guide; lot‑traceable documentation for regulatory compliance.
5. Commercial & Supply Information
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Minimum Order Quantity (MOQ): BULK 20MT (approximately 200,000 adult masks per 20‑foot container, depending on packaging density)
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Loading capacity:
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20‑ft standard container: 20–22 metric tons (approx. 220,000–240,000 units, master cartons palletized)
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40‑ft high cube container: 26–28 metric tons (approx. 280,000–310,000 units)
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Lead time: 15–25 days after PO confirmation (L/C or T/T); samples available within 7 days.
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