Disposable Face Masks

FDA UDI

Class I (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Disposable Face Masks FDA UDI
Generic Name: Anaesthesia face mask, single-use FDA UDI
Device Name: Face mask FDA UDI
Model / Reference: 000252054 FDA UDI
Description: Face mask FDA UDI

Identifiers

Catalog Number: 000252054 FDA UDI
Primary DI / UDI-DI: 05707480023288 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Anaesthesia face mask, single-use 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

MRI Safety

MR Safe FDA UDI

Category: Anaesthesia face mask, single-use

Disposable Face Masks by Ambu A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia face mask, single-use.

Ventlab — Ventlab Corp. · Class I
Resp-O2 Air Cushion Mask with Valve, Size #1, Neonate/Infant — Dynarex Corp. · Class I
Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
Vital Signs™ — Airlife, Inc. · Class I
Ventlab — Ventlab Corp. · Class I
Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
RUSCH — TELEFLEX INCORPORATED · 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: Ambu A/S

Sources (1)

FDA UDI 1f7b6e7a-12a2-4328-a361-3432a82c6e4d 37 fields · synced May 30, 2026