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Soteria Neonatal Mattress Barrier Atom Incubator ATMINC-0000

by Trinity Guardion

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850045714550 UDI-DI Date20 Oct 2025ListedStatusListed 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  • Withdrawn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
Soteria Neonatal Mattress Barrier
Generic Name
Waterproof bed mattress cover, reusable
Model / Reference
Atom Incubator ATMINC-0000
Primary DI / UDI-DI
00850045714550
FDA Product Code
FMW
GMDN Term
Waterproof bed mattress cover, reusable
Device Class
Class I
Regulation Number
880.6190
GUDID distribution status
In Commercial Distribution

Other devices from Trinity Guardion

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Properties

  • Premarket Exempt
  • Serial Number

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No