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Oxygen Mask Adult, Disposable

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref OM-81110

by Besmed Health Business Corp.

Identity

Trade Name
Oxygen Mask EUDAMED
OXYGEN MASK ADULT, DISPOSABLE FDA UDI
Generic Name
Respiratory oxygen therapy system FDA UDI
Device Name
OXYGEN MASK ADULT, DISPOSABLE EUDAMEDFDA UDI
Model / Reference
OM-81110 EUDAMEDFDA UDI
Description
OXYGEN MASK ADULT, DISPOSABLE FDA UDI

Identifiers

Primary DI / UDI-DI
04716770811109 EUDAMEDFDA UDI
Basic UDI-DI
B-04716770811109 EUDAMED
FDA Product Code
BYG FDA UDI
EMDN Code
R03010201 AIR/OXYGEN 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
France EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Oxygen Mask Adult, Disposable by Besmed Health Business Corp. — Class I — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Besmed Health Business Corp.

Sources (2)

  • FDA UDI b668efeb-a71b-4a9c-9e23-ccdf7feee973 33 fields · synced Oct 7, 2026
  • EUDAMED 8aa874c5-2cfb-4ca8-ba5b-c3bf4630eea7 61 fields · synced Jul 22, 2026