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AMICUS Apheresis Kit – Single Needle X6R2312

by Fresenius Kabi

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number04086000100090 UDI-DIDate3 Nov 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AMICUS Apheresis Kit – Single Needle
Generic Name
Apheresis system tubing set
Model / Ref / Catalog
X6R2312
Primary DI / UDI-DI
04086000100090
FDA Product Code
GKT
GMDN Term
Apheresis system tubing set
Device Class
Class II
Regulation Number
864.9245
GUDID distribution status
In Commercial Distribution

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Properties

  • Sterile
  • Single Use
  • Over-the-Counter
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No