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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 6 of 53
DeviceModel / ReferenceRegistriesClassStatus
AirLife™ 7104-HS7
FDA UDI
Class IIActive
Vital Signs™ 406554-035
FDA UDI
Class IIActive
AirLife™ 4696T
FDA UDI
Class IActive
Vital Signs™ B1353X2X
FDA UDI
Class IActive
Vital Signs™ A5Z52XXX
FDA UDI
Class IActive
Vital Signs™ A4V16XX4T
FDA UDI
Class IActive
Vital Signs™ A5Z12XXX
FDA UDI
Class IActive
Vyaire 2009101-406
FDA UDI
Class IIActive
Vital Signs™ A4UX2XX4
FDA UDI
Class IActive
AirLife™ 002016
FDA UDI
Class IActive
AirLife™ 5404DL1
FDA UDI
Class IIActive
Vital Signs™ AHAX8XX4
FDA UDI
Class IActive
Vital Signs™ 5163EL
FDA UDI
Class IActive
Vital Signs™ 5250EU
FDA UDI
Class IActive
Vital Signs™ A4U38XX4D
FDA UDI
Class IActive
Vital Signs™ 5161E
FDA UDI
Class IActive
AirLife™ FM2625
FDA UDI
Class IIActive
Vital Signs™ B14XXXX4
FDA UDI
Class IActive
AirLife™ 001905A
FDA UDI
Class IIActive
Vyaire 2009110-150
FDA UDI
Class IIActive
AirLife™ 5906-504
FDA UDI
Class IIActive
Vital Signs™ 2550VS
FDA UDI
Class IActive
Vital Signs™ A4UX6044
FDA UDI
Class IIActive
Broselow™ 7730IALS
FDA UDI
Class IIActive
AirLife™ 001260U
FDA UDI
Class IActive
Vyaire 2009101-210
FDA UDI
Class IIActive
Vital Signs™ A4U120X4
FDA UDI
Class IActive
Vital Signs™ G61CXXXX
FDA UDI
Class IActive
AirLife™ 5401L1
FDA UDI
Class IIActive
AirLife™ FM2602
FDA UDI
Class IIActive
Vyaire 2009110-050W
FDA UDI
Class IIActive
AirLife™ T60C
FDA UDI
Class IActive
Multi-Link™ 412682-002
FDA UDI
Class IIActive
Vital Signs™ AFPX20XZP
FDA UDI
Class IActive
Vital Signs™ AFR5XX20
FDA UDI
Class IActive
AirLife™ 2K8034
FDA UDI
Class IActive
Vital Signs™ A4UX20XZD
FDA UDI
Class IIActive
Vital Signs™ B17X4XV4
FDA UDI
Class IActive
AirLife™ 4863T
FDA UDI
Class IActive
AirLife™ 002003
FDA UDI
Class IIActive
Vital Signs™ AFNX204X
FDA UDI
Class IActive
Vital Signs™ 8100C
FDA UDI
Class IIActive
AirLife™ 5915-504
FDA UDI
Class IActive
Vital Signs™ A4FX2X4Z
FDA UDI
Class IActive
AirLife™ 603L
FDA UDI
Class IActive
AirLife™ 9010B
FDA UDI
Class IIActive
Vital Signs™ A4UX2444
FDA UDI
Class IActive
Vital Signs™ A1UXOXXX
FDA UDI
Class IActive
Vital Signs™ BZ1DXYXXX
FDA UDI
Class IActive
Vital Signs™ A4U52X1X
FDA UDI
Class IActive

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