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Breathewave Large

by Breathewave Technologies Inc.

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 Number00860014485268 UDI-DI Date23 Dec 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  • Withdrawn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
Breathewave
Generic Name
Nasal breathing aid, internal, reusable
Model / Reference
Large
Primary DI / UDI-DI
00860014485268
FDA Product Code
LWF
GMDN Term
Nasal breathing aid, internal, reusable
Device Class
Class I
Regulation Number
874.3900
GUDID distribution status
In Commercial Distribution

Other devices from Breathewave Technologies Inc.

Properties

  • Single Use
  • Over-the-Counter
  • Premarket Exempt

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No