AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: Inhalation therapy sterile water FDA UDI
Device Name: AirLife™ Sterile Water for INHALATION, USP FDA UDI
Model / Reference: CN0005 FDA UDI
Description: AirLife™ Sterile Water for INHALATION, USP FDA UDI

Identifiers

Catalog Number: CN0005 FDA UDI
Primary DI / UDI-DI: 10889483598634 FDA UDI
FDA Product Code: CAF FDA UDI
GMDN Term: Inhalation therapy sterile water 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

Yes

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Inhalation therapy sterile water

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

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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 9ff5f163-a0db-4225-863e-1de99fece02c 35 fields · synced Jun 8, 2026