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Nipro Techincal Solutions, Inc. Conductivity Standard Solutions 10026

by Nipro Technical Solutions, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number00850016976246 UDI-DI Date15 May 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1185-2026 FDA Class II initiated 12 Dec 2025

    due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Nipro Techincal Solutions, Inc. Conductivity Standard Solutions
Generic Name
Haemodialysis conductivity standard solution
Model / Reference
10026
Primary DI / UDI-DI
00850016976246
510(k) Number
FDA Product Code
FKH
GMDN Term
Haemodialysis conductivity standard solution
Device Class
Class II
Regulation Number
876.5820
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K041636)

Show all (12)

Other devices from Nipro Technical Solutions, Inc.

See all devices from Nipro Technical Solutions, Inc. →

Properties

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

Other properties (10)

  • Sterile: 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
  • Manufacturing Date: No