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Filtrette with Mini Mouthpiece

by Sdi Diagnostics, Inc. 2 variants

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 NumberB279S297910M050 UDI-DI Date24 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  • Withdrawn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

Generic Name
Pulmonary function testing filter/mouthpiece
Model / Ref / Catalog
Filtrette with Mini Mouthpiece, 29-7910M-050
Primary DI / UDI-DI
B279S297910M050
FDA Product Code
BZG
GMDN Term
Pulmonary function testing filter/mouthpiece
Device Class
Class II
Regulation Number
868.1840
GUDID distribution status
In Commercial Distribution

Other devices from Sdi Diagnostics, Inc.

See all devices from Sdi Diagnostics, Inc. →

Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

  • 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
  • Manufacturing Date: No