Skip to content

Inspira Air BC1640AZ

by Acclarent, Inc.

Inspira Air BC1640AZ is a Class II device made by Acclarent, Inc., listed in FDA GUDID since 31 Mar 2018 (UDI-DI 20705031147710), registry data as of 23 Oct 2026.

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

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number20705031147710 UDI-DI Date31 Mar 2018ListedStatusListed GUDID: 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  • Withdrawn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
Inspira Air
Generic name
Bronchial balloon catheter
Model / Ref / Catalog
BC1640AZ
Primary DI / UDI-DI
20705031147710
FDA product code
KTI
GMDN term
Bronchial balloon catheter
Device class
Class II
Regulation number
874.4680
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code KTI (Bronchoscope accessory).

Other devices from Acclarent, Inc.

See all devices from Acclarent, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)