Mask

FDA UDI

Class I (US FDA UDI)

by Westmed, Inc.

Identity

Trade Name: Mask FDA UDI
Generic Name: Aerosol face mask, non-rebreathing FDA UDI
Device Name: Mask Oxygen Adult W/7' Kink Resistant Tubing Standard Connector FDA UDI
Model / Reference: 1002228 FDA UDI
Description: Mask Oxygen Adult W/7' Kink Resistant Tubing Standard Connector FDA UDI

Identifiers

Primary DI / UDI-DI: 00709078014345 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Aerosol face mask, non-rebreathing

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

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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

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Manufacturer

Manufacturer: Westmed, Inc.

Sources (1)

FDA UDI 847fa799-61ef-4743-a09c-735f5415b5a9 33 fields · synced May 31, 2026