Aerosol Masks

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Aerosol Masks FDA UDI
Generic Name: Aerosol face mask, non-rebreathing FDA UDI
Device Name: Aerosol Mask, Pediatric, Single Vents FDA UDI
Model / Reference: 0251 FDA UDI
Description: Aerosol Mask, Pediatric, Single Vents FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078011405 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Aerosol face mask, non-rebreathing FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5580 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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Aerosol face mask, non-rebreathing

Aerosol Masks by Westmed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Aerosol face mask, non-rebreathing.

BF — Allied Medical LLC · Class I
MedSource Aerosol Mask — MEDSOURCE INTERNATIONAL LLC · Class I
Curaplex — BOUND TREE MEDICAL, LLC · Class I
AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
AMSure® Aerosol Drainage System — AMSINO INTERNATIONAL, INC. · Class I
HUDSON RCI — MEDLINE INDUSTRIES, INC. · Class I
MedSource Aerosol Mask — MEDSOURCE INTERNATIONAL LLC · Class I
MedSource Aerosol Mask — MEDSOURCE INTERNATIONAL LLC · 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

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

Manufacturer

Manufacturer: Westmed, Inc.

Sources (1)

FDA UDI b37bcb70-e54e-484c-9a5a-97a48af67965 33 fields · synced Jun 8, 2026