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8100-0

by Salter Labs, LLC

8100-0 is a Class I device made by Salter Labs, LLC, listed in FDA GUDID since 30 Nov 2016 (UDI-DI 00607411800269), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00607411800269 UDI-DI Date30 Nov 2016ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic name
Aerosol face mask, non-rebreathing
Model / Ref / Catalog
8100-0
Primary DI / UDI-DI
00607411800269
FDA product code
BYG
GMDN term
Aerosol face mask, non-rebreathing
Device class
Class I
Regulation number
868.5580
GUDID distribution status
In Commercial Distribution

Related devices

Category: Aerosol face mask, non-rebreathing

Similar devices

Other devices filed under FDA product code BYG (MASK, OXYGEN).

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 (11, all answered No)