AirLife™

FDA UDI

Class I (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: Tracheostomy mask, aerosol FDA UDI
Device Name: AirLife™ Adult Tracheostomy Mask (Large) FDA UDI
Model / Reference: 001227 FDA UDI
Description: AirLife™ Adult Tracheostomy Mask (Large) FDA UDI

Identifiers

Catalog Number: 001227 FDA UDI
Primary DI / UDI-DI: 10889483569436 FDA UDI
FDA Product Code: BYF FDA UDI
GMDN Term: Tracheostomy mask, aerosol FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5600 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Tracheostomy mask, aerosol

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

Similar devices

Also classified as Tracheostomy mask, aerosol.

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MedSource Tracheostomy Mask — MEDSOURCE INTERNATIONAL LLC · Class I
Vital Signs™ — VYAIRE MEDICAL, INC. · Class I
Trach O-Life — CUTTING EDGE HC BRANDS LLC · Class I
Circulaire — WESTMED, INC. · Class I
AMSure® Tracheostomy Mask — AMSINO INTERNATIONAL, INC. · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI 4e0e66ab-5d90-4c16-9f1e-b7cd575ab6df 35 fields · synced Jun 8, 2026