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Sign in to claim this brandAirlife, Inc.
US
Last updated May 23, 2026
What Airlife, Inc. makes
Airlife, Inc. manufactures single-use anaesthesia and ventilator breathing circuits, manual pulmonary resuscitators, reusable electrocardiographic lead sets, and single-use connectors for respiratory support. Their portfolio also includes benchtop therapeutic agent nebulizers, single-use cardiopulmonary resuscitation kits, and single-use electrocardiographic electrodes.
These devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s UDI (Unique Device Identification) database. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Airlife, Inc. manufacture?
Airlife, Inc. specializes in respiratory and cardiac support devices. Their product portfolio includes single-use anaesthesia and ventilator breathing circuits, manual pulmonary resuscitators, reusable electrocardiographic lead sets, and single-use connectors for respiratory systems. They also produce benchtop therapeutic agent nebulizers, single-use cardiopulmonary resuscitation kits, and single-use electrocardiographic electrodes. These devices are designed for critical care, anaesthesia, and emergency resuscitation settings.
Where is Airlife, Inc. based?
Airlife, Inc. is headquartered in the United States. The company’s location in the US aligns with regulatory frameworks like the FDA’s UDI database, where their devices are listed for traceability and compliance purposes.
Which regulatory registries list Airlife, Inc.’s devices?
Airlife, Inc.’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry ensures transparency and traceability of medical devices under FDA oversight, particularly for Class I and Class II products, which require identification for regulatory tracking.
How are Airlife, Inc.’s devices classified under FDA regulations?
Airlife, Inc.’s devices fall into FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and often require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, intended use, and potential risks, as outlined in FDA guidelines.
Why are some of Airlife’s devices reusable while others are single-use?
The reusability of a device depends on its design, risk level, and intended use. For example, reusable electrocardiographic lead sets are engineered to withstand repeated sterilization and use without compromising performance or patient safety. In contrast, single-use devices like anaesthesia breathing circuits or resuscitation kits are designed for one-time use to minimize infection risks and ensure consistent sterility, aligning with FDA’s risk-based classification approach.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (2607)
Page 52 of 53| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tempo2-I Disposable Thermometers | K790890 | FDA 510(k) | Class I | Active |
| Humidifier | K802852 | FDA 510(k) | Class II | Active |
| Disposable Trach T Oxygenator | K811890 | FDA 510(k) | Class I | Active |
| Single Use Nebulizer, Adjust. Air- | K830895 | FDA 510(k) | Class II | Active |
| Trach T With One-Way Valves | K790888 | FDA 510(k) | Class I | Active |
| Tubing, E.v.a. Flexible | K790158 | FDA 510(k) | Class I | Active |
| Cuff Connector | K790148 | FDA 510(k) | Class I | Active |
| Dual Dial Venturi Style Mask | K832725 | FDA 510(k) | Class I | Active |
| Air Incentive Spirometer | K791819 | FDA 510(k) | Class II | Active |
| I.p.p.b. Manifolds & Neb. Sing. & Dbl | K791820 | FDA 510(k) | Class II | Active |
| Oxygen Mask W/Reservoir Bag | K790161 | FDA 510(k) | Class I | Active |
| Single Use Nebulizer-Adjust-Air Entrain | K834077 | FDA 510(k) | Class II | Active |
| Air Entrainment Trach T | K810947 | FDA 510(k) | Class I | Active |
| Aqua Trap | K834573 | FDA 510(k) | Class I | Active |
| Humidifier, With Or Without Adapter | K830896 | FDA 510(k) | Class I | Active |
| Oxygen Tubing (crush Resistant)/Vinyl Tp | K801190 | FDA 510(k) | Class I | Active |
| Tee Adapter | K792364 | FDA 510(k) | Class II | Active |
| Air Incentive Spirometer, W/Nebulizer | K792217 | FDA 510(k) | Class II | Active |
| Disposable Thermoplastic Rubber Mouth | K821128 | FDA 510(k) | Class I | Active |
| Tempo2-Ii Disposable Thermometers | K790891 | FDA 510(k) | Class II | Active |
| Face Tent-Vinyl | K790884 | FDA 510(k) | N/A | Active |
| Universal Adapter System-U/Adapit | K811708 | FDA 510(k) | Class I | Active |
| Corrugated Flexible Polyethylene & Eva | K791821 | FDA 510(k) | Class I | Active |
| Nebulizer With Air Entertainer & Etc. | K801252 | FDA 510(k) | Class II | Active |
| Whistler In-Line Pressure Release Valve | K831246 | FDA 510(k) | Class II | Active |
| Inspiratory Force Pressure Adaptor | K812067 | FDA 510(k) | Class I | Active |
| Two-Piece Ippb Manifold For Supply Line | K791443 | FDA 510(k) | Class II | Active |
| Pediatric Anesthesia Breathing Circuits | K800499 | FDA 510(k) | Class I | Active |
| Y & Elbow W/Wo Ports | K791856 | FDA 510(k) | Class I | Active |
| Corrugated Flexible Polyethylene | K790886 | FDA 510(k) | N/A | Active |
| Misty Nebulizer | K790892 | FDA 510(k) | Class II | Active |
| Mask, Percento | K790146 | FDA 510(k) | Class I | Active |
| Circuit, Breathing (w/ Connector, Adapt, | K792047 | FDA 510(k) | Class I | Active |
| Trach T Adapter | K790157 | FDA 510(k) | Class I | Active |
| Percento Mask, Pediatric, Under-The-Chin | K812066 | FDA 510(k) | Class I | Active |
| Oxygen Mask Rebreather | K790164 | FDA 510(k) | Class I | Active |
| Pediatric Oxygen Or Aerosol Masks, | K802323 | FDA 510(k) | Class I | Active |
| Volume Ventilator Circuit W/Water Trap | K834570 | FDA 510(k) | Class I | Active |
| Ventilator Elbow W/Suction Port | K790155 | FDA 510(k) | Class I | Active |
| Circuit, Breathing W/Wo Nebulizer | K791761 | FDA 510(k) | Class I | Active |
| Misty Bebulizer | K792218 | FDA 510(k) | Class II | Active |
| Two-Piece I.p.p.b. Manifold-With Right | K792030 | FDA 510(k) | Class I | Active |
| Bird Drive Line Adaptor | K790150 | FDA 510(k) | Class I | Active |
| Two-Piece Ippb Manifold Machines | K791445 | FDA 510(k) | Class II | Active |
| Trach Swive/Connector | K833197 | FDA 510(k) | Class II | Active |
| Manifold, Universal I.p.p.b | K790152 | FDA 510(k) | Class II | Active |
| Mouthpiece, Universal | K790066 | FDA 510(k) | Class I | Active |
| I.p.p.b. Manifold & Nebulizer, Universal | K791042 | FDA 510(k) | Class II | Active |
| Nasal, Oxygen, Cannula | K790885 | FDA 510(k) | Class I | Active |
| Volume Ventilator Circuit-Nebulizer | K833196 | FDA 510(k) | Class I | Active |
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