Aerosol Mask, Child, Dog Type.

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref OM-82110

by Besmed Health Business Corp.

Identity

Trade Name: Aerosol Mask EUDAMED
AEROSOL MASK, CHILD,DOG TYPE. FDA UDI
AEROSOL MASK, ADULT FDA UDI
Generic Name: Respiratory oxygen therapy system FDA UDI
Device Name: AEROSOL MASK, ADULT EUDAMEDFDA UDI
AEROSOL MASK, CHILD,DOG TYPE. FDA UDI
Model / Reference: OM-82110 EUDAMEDFDA UDI
OM-82500 FDA UDI
Description: AEROSOL MASK, CHILD,DOG TYPE. FDA UDI
AEROSOL MASK, ADULT FDA UDI

Identifiers

Primary DI / UDI-DI: 04716770821108 EUDAMEDFDA UDI
04716770825007 FDA UDI
Basic UDI-DI: B-04716770821108 EUDAMED
FDA Product Code: BYG FDA UDI
EMDN Code: R03010301 AEROSOL THERAPY MASKS EUDAMED
GMDN Term: Respiratory oxygen therapy system FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class I FDA UDI
Regulation Number: 868.5580 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

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

Category: Respiratory oxygen therapy system

Aerosol Mask, Child, Dog Type. by Besmed Health Business Corp. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Respiratory oxygen therapy system.

02-RESQ — Pulmodyne Inc. · Class II
02-RESQ — Pulmodyne Inc. · Class II
GO-PAP — Pulmodyne Inc. · Class II
O2-RESQ — Pulmodyne Inc. · Class II
O2-MAX — Pulmodyne Inc. · Class II
Infant Flow™ — VYAIRE MEDICAL, INC. · Class II
AincA — Anesthesia Associates, Inc. · Class II
Infant Flow — VYAIRE MEDICAL, INC. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Besmed Health Business Corp.

Sources (3)

FDA UDI 64c712ed-41a9-4c2f-9b3d-b42bdbab0a57 33 fields · synced Jul 14, 2026
FDA UDI c64da3fe-fdf2-48e6-a760-eb7c5a8f35c7 33 fields · synced May 30, 2026
EUDAMED f104655e-c944-45a5-823e-b3c770029b6f 61 fields · synced Jul 14, 2026