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Soteria Mattress Barrier Universal 84x35x8 843508-0E00

by Trinity Guardion

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850045714567 UDI-DI Date8 Dec 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Soteria Mattress Barrier
Generic Name
Waterproof bed mattress cover, reusable
Model / Reference
Universal 84x35x8 843508-0E00
Primary DI / UDI-DI
00850045714567
510(k) Number
FDA Product Code
QTV
GMDN Term
Waterproof bed mattress cover, reusable
Device Class
Class I
Regulation Number
880.6190
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K201876)

Show all (12)

Other devices from Trinity Guardion

See all devices from Trinity Guardion →

Properties

  • Serial Number

Other properties (13)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No