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3100A/B 22151-801

by Carefusion

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number10846446005776 UDI-DI Date1 May 2017ListedStatusListed GUDID: not in commercial distribution

Recalls

1 recall · FDA

    • Completed Z-0488-2024 FDA Class II initiated 27 Oct 2023

    Two patient circuits, 29028-003 and 29028-004, for the 3100 High Frequency Oscillatory ventilator that are only approved for use outside the U.S. were distributed in the U.S.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
3100A/B
Generic Name
Stationary electric high-frequency ventilator
Model / Ref / Catalog
22151-801
Primary DI / UDI-DI
10846446005776
PMA Number
FDA Product Code
LSZ
GMDN Term
Stationary electric high-frequency ventilator
Device Class
Class III
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (P890057)

Show all (12)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Prescription Use
  • Serial Number

Other properties (12)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No