Skip to content

AEROECLIPSE BAN Replacement Mouthpiece Assembly 105509

by Trudell Medical International

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number62860105509026 UDI-DI Date24 Mar 2020ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AEROECLIPSE BAN Replacement Mouthpiece Assembly
Generic Name
Therapeutic agent nebulizer, benchtop
Model / Ref / Catalog
105509, 10550994080
Primary DI / UDI-DI
62860105509026
510(k) Number
FDA Product Code
CAF
GMDN Term
Therapeutic agent nebulizer, benchtop
Device Class
Class II
Regulation Number
868.5630
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K080926)

Other devices from Trudell Medical International

See all devices from Trudell Medical International →

Properties

  • Over-the-Counter
  • Lot / Batch Number

Other properties (12)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No