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AfterSwim 530

by Bionix, LLC

AfterSwim 530, an ear canal drying sponge (FDA Class I; FDA product code KXF, Applicator, Absorbent Tipped, Non-Sterile) made by Bionix, LLC, was listed in FDA GUDID on 19 Jul 2023 (UDI-DI 00859911004009); the registry lists it as not in commercial distribution (GUDID) as of 22 Oct 2026.

Listed FDA GUDID listing, not in commercial distribution

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

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00859911004009 UDI-DI Date19 Jul 2023ListedStatusListed GUDID: not in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
AfterSwim
Generic name
Ear canal drying sponge
Model / Ref / Catalog
530
Primary DI / UDI-DI
00859911004009
FDA product code
KXF
GMDN term
Ear canal drying sponge
Device class
Class I
Regulation number
880.6025
GUDID distribution status
Not in Commercial Distribution

Similar devices

Other devices filed under FDA product code KXF (APPLICATOR, ABSORBENT TIPPED, NON-STERILE).

Other devices from Bionix, LLC

See all devices from Bionix, LLC →

Properties

  • Single use
  • Over-the-counter
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)