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FX CorAL F00012974

by Fresenius Medical Care

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 Number04039361259631 UDI-DIDate2 Jan 2026ListedStatusListed 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  • Withdrawn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
FX CorAL
Generic Name
Hollow-fibre haemodialysis dialyser, single-use
Model / Reference
F00012974
Primary DI / UDI-DI
04039361259631
FDA Product Code
KDI
GMDN Term
Hollow-fibre haemodialysis dialyser, single-use
Device Class
Class II
Regulation Number
876.5860
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 2.0 Square meter

Other devices from Fresenius Medical Care

See all devices from Fresenius Medical Care →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (8)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No