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ACCUSOL Dialysis Solution for CRRT 30 2K+ 0Ca++

by Nikkiso Belgium BVBA

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 Number09349285000192 UDI-DI Date30 Jun 2016ListedStatusListed 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  • Withdrawn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
ACCUSOL Dialysis Solution for CRRT
Generic Name
Haemodialysis concentrate
Model / Ref / Catalog
30 2K+ 0Ca++, 5B9252
Primary DI / UDI-DI
09349285000192
510(k) Number
FDA Product Code
KPO
GMDN Term
Haemodialysis concentrate
Device Class
Class II
Regulation Number
876.5820
GUDID distribution status
Not in Commercial Distribution
Size
Total Volume — 2500 Milliliter

Properties

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

Other properties (9)

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