AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: Pressure relief valve, single-use FDA UDI
Device Name: AirLife DuoTherm® Pressure Relief Valve, 40 cm H2O FDA UDI
Model / Reference: AH115-05E FDA UDI
Description: AirLife DuoTherm® Pressure Relief Valve, 40 cm H2O FDA UDI

Identifiers

Catalog Number: AH115-05E FDA UDI
Primary DI / UDI-DI: 10889483595831 FDA UDI
FDA Product Code: BTT FDA UDI
GMDN Term: Pressure relief valve, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5450 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

Yes

FDA UDI

Category: Pressure relief valve, single-use

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

Similar devices

Also classified as Pressure relief valve, single-use.

Pressure Relief Valve For High Flow Oxygen Therapy 60cmH20 — FLEXICARE MEDICAL LIMITED · Class I
FISHER & PAYKEL HEALTHCARE — FISHER & PAYKEL HEALTHCARE, INC. · Class II
Pressure Relief Valve For High Flow Oxygen Therapy 40cmH20 — FLEXICARE MEDICAL LIMITED · Class I
Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI 57107722-23b5-4c7e-a40f-7d1c61e473c9 36 fields · synced Jun 6, 2026