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AirLife 5097PF

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number10885403293276 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

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  • Withdrawn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
Pulmonary function testing filter/mouthpiece
Model / Ref / Catalog
5097PF
Primary DI / UDI-DI
10885403293276
510(k) Number
FDA Product Code
CAH
GMDN Term
Pulmonary function testing filter/mouthpiece
Device Class
Class II
Regulation Number
868.5260
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K033008)

Show all (12)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing 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
  • Expiration Date: No