Skip to content

AeroNOx 2.0 Nitric Oxide Delivery Device AeroNOx NO Supply Hose

by International Biomedical, Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850018561655 UDI-DI Date19 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AeroNOx 2.0 Nitric Oxide Delivery Device
Generic Name
Nitric oxide delivery unit, system-based
Model / Ref / Catalog
AeroNOx NO Supply Hose, 731-1862
Primary DI / UDI-DI
00850018561655
510(k) Number
FDA Product Code
MRN
GMDN Term
Nitric oxide delivery unit, system-based
Device Class
Class II
Regulation Number
868.5165
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K193481)

Show all (9)

Other devices from International Biomedical, Ltd.

See all devices from International Biomedical, Ltd. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

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