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Sovereign America 2000SM1

by Sovereign America

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 Number00763267031377 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Sovereign America
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Reference
2000SM1
Primary DI / UDI-DI
00763267031377
FDA Product Code
FXX
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, non-antimicrobial, single-use

Other devices from Sovereign America

Properties

  • Single Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No