Skip to content

Non-rebreathing mask, adult

by Besmed Health Business Corp.

Ref OM-81212

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-OM-812124G Basic UDI-DI D-OM-812124GUDI-DIDate5 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-OM-812124G UDI-DI Date20 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Non-rebreathing mask, adult EUDAMED
Hi-Oxygen Mask Adult, with 7FT Tube,single Packing GUDID
Generic Name
Respiratory oxygen therapy system
Device Name
Non-rebreathing mask, 7ft tube, Adult
Model / Reference
OM-81212
Primary DI / UDI-DI
D-OM-812124G EUDAMED
04716770812120 GUDID
Basic UDI-DI
B-OM-812124G
FDA Product Code
BYG
EMDN Code
R03010201 Air/oxygen masks
GMDN Term
Respiratory oxygen therapy system
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5580
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-OM-812124G
GUDID
04716770812120
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
TW-MF-000007246
Authorised representative
mdi Europa GmbH DE-AR-000006218

Other devices from Besmed Health Business Corp.

See all devices from Besmed Health Business Corp. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No