AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: Therapeutic agent nebulizer, benchtop FDA UDI
Device Name: AirLife™ Misty Fast™ Direct Connect Large Volume Continuous Nebulizer With Adult Aerosol Mask and 2.4 m/15 cm (8 foot /6 inch) Segmented Clear Aerosol Tubing FDA UDI
Model / Reference: 002502 FDA UDI
Description: AirLife™ Misty Fast™ Direct Connect Large Volume Continuous Nebulizer With Adult Aerosol Mask and 2.4 m/15 cm (8 foot /6 inch) Segmented Clear Aerosol Tubing FDA UDI

Identifiers

Catalog Number: 002502 FDA UDI
Primary DI / UDI-DI: 10889483571255 FDA UDI
510(k) Number: K041418 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Therapeutic agent nebulizer, benchtop FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5630 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Therapeutic agent nebulizer, benchtop

AirLife™ by Airlife, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K041418 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI 697ed6c4-b66f-4a89-b7b5-1b75e56117b5 36 fields · synced May 29, 2026