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DIASAFE®plusUS F00013010

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 Number04039361261313 UDI-DIDate1 May 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  • Withdrawn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
DIASAFE®plusUS
Generic Name
Haemodialysis system dialysate pyrogen filter
Model / Ref / Catalog
F00013010
Primary DI / UDI-DI
04039361261313
510(k) Number
FDA Product Code
FIP
GMDN Term
Haemodialysis system dialysate pyrogen filter
Device Class
Class II
Regulation Number
876.5665
GUDID distribution status
In Commercial Distribution
Size
Area/Surface Area — 2.1 Square meter

Other devices from Fresenius Medical Care

See all devices from Fresenius Medical Care →

Properties

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

Other properties (10)

  • 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
  • Serial Number: No