AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: PEEP valve, single-use FDA UDI
Device Name: Positive End Expiratory Pressure (PEEP) Valve (5–20 cmH2O) with 22 mm Adapter FDA UDI
Model / Reference: 2K8082 FDA UDI
Description: Positive End Expiratory Pressure (PEEP) Valve (5–20 cmH2O) with 22 mm Adapter FDA UDI

Identifiers

Catalog Number: 2K8082 FDA UDI
Primary DI / UDI-DI: 10190752141575 FDA UDI
FDA Product Code: BTM FDA UDI
GMDN Term: PEEP valve, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5915 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

MRI Safety

MR Conditional FDA UDI

Category: PEEP valve, single-use

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

Similar devices

Also classified as PEEP valve, single-use.

PEEP VALVE 5cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
PEEP VALVE 2.5cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
O2-CPAP — Pulmodyne Inc. · Class II
PEEP VALVE 10cmH2O — BESMED HEALTH BUSINESS CORP. · Class II
O2-CPAP — Pulmodyne Inc. · Class II
Whisperflow CPAP Valve — Respironics Novametrix, LLC · Class II
PEEP VALVE 15cmH2O;STRAIGHT CONNECTORS 30m, 22m — BESMED HEALTH BUSINESS CORP. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · 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

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI ae0b3b52-d84a-4609-8e95-4156cf85bf87 36 fields · synced May 29, 2026