Skip to content

Air Caloric Irrigator AirC

by ISEN Tech. & Trading Co., Ltd.

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 Number06980291491135 UDI-DI Date27 Jul 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  • Withdrawn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
Air Caloric Irrigator
Generic Name
Diagnostic caloric vestibular stimulation system
Model / Reference
AirC
Primary DI / UDI-DI
06980291491135
FDA Product Code
KHH
GMDN Term
Diagnostic caloric vestibular stimulation system
Device Class
Class I
Regulation Number
874.1800
GUDID distribution status
In Commercial Distribution

Other devices from ISEN Tech. & Trading Co., Ltd.

Properties

  • Prescription Use
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No