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n/a SO-407-0

by Salter Labs, LLC

Ref SO-407Model Salter Oxygen Masks

Active European Union. Also listed in GUDID (US).

CE MDR

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0607411TF20014a_O2MaskLW Basic UDI-DI 00607411800818UDI-DIDate29 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00607411800818 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Oxygen Mask (Adult) Medium Concentration, 7’ (2.1 m) supply tube, elastic strap fixation
Generic Name
Non-rebreathing oxygen face mask
Model / Ref / Catalog
Salter Oxygen Masks EUDAMED
SO-407 EUDAMED
SO-407-0 GUDID
Primary DI / UDI-DI
00607411800818
Basic UDI-DI
0607411TF20014a_O2MaskLW
FDA Product Code
BYG
EMDN Code
R03010201 Air/oxygen masks
GMDN Term
Non-rebreathing oxygen face mask
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
868.5580
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Salter Oxygen Masks
SO-407
GUDID
SO-407-0
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Non-rebreathing oxygen face mask

Other devices from Salter Labs, LLC

See all devices from Salter Labs, LLC →

Properties

  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No