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Earflo EF001

by Earflo, 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 Number00860014369506 UDI-DIDate31 Mar 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  • Withdrawn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
Earflo
Generic Name
Middle ear decompressor, positive pressure
Model / Reference
EF001
Primary DI / UDI-DI
00860014369506
510(k) Number
FDA Product Code
MJV
GMDN Term
Middle ear decompressor, positive pressure
Device Class
U
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 72 Millimeter
Height — 165 Millimeter

Other devices from Earflo, Inc.

  • Earflo (EF001)

    Unclassified

Properties

  • Over-the-Counter
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No