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AirLife 2K8080

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 Number10885403175985 UDI-DI Date24 Oct 2015ListedStatusListed 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  • Withdrawn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
PEEP valve, single-use
Model / Ref / Catalog
2K8080
Primary DI / UDI-DI
10885403175985
510(k) Number
FDA Product Code
BYE
GMDN Term
PEEP valve, single-use
Device Class
Class II
Regulation Number
868.5965
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Conditional
Size
Outer Diameter — 30.00 Millimeter

Related devices

Cleared under the same submission (K133957)

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