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Bicarby RFP-453-G

by Fresenius Medical Care Renal Therapies Group, LLC

Listed FDA GUDID listing, no authorization on record

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 Number00840861103119 UDI-DI Date18 Dec 2025ListedStatusListed GUDID: 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  • Withdrawn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
Bicarby
Generic Name
Haemodialysis dialysate solution
Model / Reference
RFP-453-G
Primary DI / UDI-DI
00840861103119
510(k) Number
FDA Product Code
KPO
GMDN Term
Haemodialysis dialysate solution
Device Class
Class II
Regulation Number
876.5820
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 5000 Milliliter

Related devices

Cleared under the same submission (K252180)

Other devices from Fresenius Medical Care Renal Therapies Group, LLC

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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