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n/a 8110-7

by Salter Labs, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607411800306 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Non-rebreathing oxygen face mask
Model / Ref / Catalog
8110-7
Primary DI / UDI-DI
00607411800306
FDA Product Code
BYG
GMDN Term
Non-rebreathing oxygen face mask
Device Class
Class I
Regulation Number
868.5580
GUDID distribution status
In Commercial Distribution

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 (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No