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Airlife, 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.

Information

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US
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Catalogue (2607)

Page 51 of 53
DeviceModel / ReferenceRegistriesClassStatus
Vital Signs™ A8UX204X
FDA UDI
Class IIActive
AirLife™ AH102
FDA UDI
Class IIActive
Vital Signs™ B1734XX4
FDA UDI
Class IActive
AirLife™ NIV041M
FDA UDI
Class IIActive
Vital Signs™ A46XXXXX
FDA UDI
Class IActive
AirLife™ TMS-09 ADJ
FDA UDI
Class IActive
AirLife™ 001840
FDA UDI
Class IActive
AirLife™ 2K8082
FDA UDI
Class IIActive
Vital Signs™ AFNX1900
FDA UDI
Class IActive
Vital Signs™ 5104BV
FDA UDI
Class IActive
Vital Signs™ A4FX2XXZD
FDA UDI
Class IActive
AirLife™ 004050
FDA UDI
Class IActive
Vital Signs™ GFNXX0X4BX6FOXGX
FDA UDI
Class IActive
Vital Signs™ AGNXOXXC
FDA UDI
Class IActive
Vital Signs™ A8U52XAX
FDA UDI
Class IActive
AirLife™ 002434
FDA UDI
Class IIActive
Vital Signs™ A5U32020
FDA UDI
Class IActive
Vital Signs™ AFNX8X04
FDA UDI
Class IActive
Oxygen Mask-High Concentration K790165
FDA 510(k)
Class IActive
Broselow™ 7700GIN
FDA UDI
Class IIActive
AirLife™ Hygroscopic Condenser Humidfier 5704EU
FDA UDI
Class IActive
SuperNO2VA SEL-20-CE
FDA UDI
Class IIActive
GreenLight™ 4011GSP
FDA UDI
Class IActive
Halyard Gas Sampling Line ABC3004
FDA UDI
Class IIActive
Broselow™ BPOC01A
FDA UDI
Class IIActive
enFlow™ 980202EU
FDA UDI
Class IIActive
SuperNO2VA SSL-20
FDA UDI
Class IIActive
Broselow™ 7700WAW
FDA UDI
Class IIActive
RediTube™ 8050RTC
FDA UDI
Class IIActive
GreenLight™ 4012GSP
FDA UDI
Class IActive
Broselow™ 7733GRN
FDA UDI
Class IIActive
Broselow™ 7730FLYY
FDA UDI
Class IIActive
SuperNO2VA SSEL-20-CE
FDA UDI
Class IIActive
GreenLight™ 4611EU
FDA UDI
Class IActive
Aerosol Mask K790163
FDA 510(k)
Class IActive
Tubing Corrugated K790147
FDA 510(k)
Class IActive
Oxygen Mask, Concentration Aerosol Mask K790162
FDA 510(k)
Class IActive
Adult & Pediatric Tracheostomy Masks K810946
FDA 510(k)
Class IActive
Blow-By-Set-Up Connector-Airway K802663
FDA 510(k)
Class IActive
One-Way Valve K790151
FDA 510(k)
Class IIActive
Manifold, W/Corrugated Tubing K790153
FDA 510(k)
Class IIActive
Circuit, Breathing (w Connec, Y Piece) K790889
FDA 510(k)
N/AActive
Misty Nebulizer K802477
FDA 510(k)
Class IIActive
Airlife Nebulizer Heater K821129
FDA 510(k)
Class IIActive
Corrugated Flexible E.v.a. Tubing K790159
FDA 510(k)
Class IActive
Trach Mist Unit W/Or Without Elbow K800990
FDA 510(k)
Class IActive
Trach T W/Drainage Bag K790156
FDA 510(k)
Class IActive
Pediatric Oxygen Masks K811711
FDA 510(k)
Class IActive
Mask Intulation Adaptor K790149
FDA 510(k)
Class IActive
Humidifier W/ Or W/Out Adaptor K811161
FDA 510(k)
Class IActive

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