AirLife™

FDA UDI

Class II (US FDA UDI)

by Airlife, Inc.

Identity

Trade Name: AirLife™ FDA UDI
Generic Name: Incentive spirometer FDA UDI
Device Name: Volume Incentive Spirometer 4000 mL, in Drawstring Bag FDA UDI
Model / Reference: RESOC4909A FDA UDI
Description: Volume Incentive Spirometer 4000 mL, in Drawstring Bag FDA UDI

Identifiers

Catalog Number: RESOC4909A FDA UDI
Primary DI / UDI-DI: 10190752117716 FDA UDI
FDA Product Code: OGL FDA UDI
GMDN Term: Incentive spirometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.5655 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

FDA UDI

Category: Incentive spirometer

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

Similar devices

Also classified as Incentive spirometer.

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AincA® — Anesthesia Associates, Inc. · Class II
AincA® — Anesthesia Associates, Inc. · Class II
THRESHOLD — RESPIRONICS RESPIRATORY DRUG DELIVERY (UK) LTD · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Portex — ICU MEDICAL, 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

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Manufacturer

Manufacturer: Airlife, Inc.

Sources (1)

FDA UDI 063f9f5f-4a97-4807-a6cf-d2e2725b8c84 35 fields · synced Jun 1, 2026