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AirLife AH290

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

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 Number10885403276231 UDI-DI Date1 May 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0345-2018 FDA Class I initiated 29 Nov 2014
    • Terminated Z-0343-2018 FDA Class I initiated 29 Nov 2014
    • Terminated Z-0344-2018 FDA Class I initiated 29 Nov 2014
    • Terminated Z-0346-2018 FDA Class I initiated 29 Nov 2014

    Manufacturing error in humidification chamber may cause an overfill/overflow condition of the chamber. The may case a water back-up into the patient circuit resulting in an excessive amount of water entering the airway/lungs of the ventilated patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AirLife
Generic Name
Inspiratory line humidification chamber, single-use
Model / Ref / Catalog
AH290
Primary DI / UDI-DI
10885403276231
510(k) Number
FDA Product Code
BTT
GMDN Term
Inspiratory line humidification chamber, single-use
Device Class
Class II
Regulation Number
868.5450
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K160764)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: 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
  • Manufacturing Date: No