Silicone Face Mask

FDA UDI

Class I (US FDA UDI)

by Ambu A/S

Identity

Trade Name: Silicone Face Mask FDA UDI
Generic Name: Resuscitator face mask, reusable FDA UDI
Device Name: Reusable face mask FDA UDI
Model / Reference: 000315000 FDA UDI
Description: Reusable face mask FDA UDI

Identifiers

Catalog Number: 000315000 FDA UDI
Primary DI / UDI-DI: 05707480030453 FDA UDI
FDA Product Code: BYG FDA UDI
GMDN Term: Resuscitator face mask, reusable 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

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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Resuscitator face mask, reusable

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

Similar devices

Also classified as Resuscitator face mask, reusable.

mada — ENTER MEDICAL CORPORATION · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
Rescuer Silicone Resuscitation Mask (#5 Adult) — B.L.S. Systems Limited · Class I
FERNO2 — SPIRACLE TECHNOLOGY · Class I
Rescuer Silicone Resuscitation Mask (#4 Adult) — B.L.S. Systems Limited · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
HUDSON RCI — TELEFLEX INCORPORATED · Class I
Rescuer Silicone Resuscitation Mask (#1 Infant) — B.L.S. Systems Limited · 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: Ambu A/S

Sources (1)

FDA UDI f80732ed-b0e1-4584-a3c5-4e4d9817a95c 37 fields · synced May 30, 2026