Skip to content

Aurora Xi 6112592378

by Fresenius Kabi

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811137013012 UDI-DIDate8 Aug 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Aurora Xi
Generic Name
Apheresis system
Model / Ref / Catalog
6112592378
Primary DI / UDI-DI
00811137013012
FDA Product Code
GKT
GMDN Term
Apheresis system
Device Class
Class II
Regulation Number
864.9245
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (BK241135)

Other devices from Fresenius Kabi

See all devices from Fresenius Kabi →

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