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HiNasal Air-B-Pro

by Mainiusi Intelligent Medical Technology (Suzhou) 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number06974592850494 UDI-DI Date15 Sep 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  • Withdrawn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
HiNasal
Generic Name
Nasal irrigation applicator
Model / Reference
Air-B-Pro
Primary DI / UDI-DI
06974592850494
FDA Product Code
KMA
GMDN Term
Nasal irrigation applicator
Device Class
Class I
Regulation Number
874.5550
GUDID distribution status
In Commercial Distribution

Other devices from Mainiusi Intelligent Medical Technology (Suzhou) Co., Ltd.

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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