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Vela 10684

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 Number10846446001679 UDI-DIDate23 Jun 2017ListedStatusListed 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  • Withdrawn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
Vela
Generic Name
Ventilator breathing circuit, single-use
Model / Ref / Catalog
10684
Primary DI / UDI-DI
10846446001679
510(k) Number
FDA Product Code
CBK
GMDN Term
Ventilator breathing circuit, single-use
Device Class
Class II
Regulation Number
868.5895
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K093094)

Other devices from Carefusion

See all devices from Carefusion →

Properties

  • Prescription Use
  • Manufacturing Date

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
  • Serial Number: No
  • Expiration Date: No