Skip to content

HEAT AND MOISTURE EXCHANGER FOR TRACHEOSTOMY FOAM Fl51305

by Assomedika, Ooo

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 Number04816415501102 UDI-DI Date19 May 2026ListedStatusListed 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  • Withdrawn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
Heat and Moisture Exchanger for Tracheostomy Foam
Generic Name
Heat/moisture exchanger, single-use
Model / Reference
Fl51305
Primary DI / UDI-DI
04816415501102
FDA Product Code
BYD
GMDN Term
Heat/moisture exchanger, single-use
Device Class
Class I
Regulation Number
868.5375
GUDID distribution status
In Commercial Distribution

Other devices from Assomedika, Ooo

See all devices from Assomedika, Ooo →

Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (7)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No