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RAPIDPOINT®340/350 pH Electrode 10375796

by Siemens Healthcare Diagnostics 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 Number00630414566245 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1370-2026 FDA Class II initiated 31 Dec 2025

    A systematic positive bias of up to 20% was identified across the reportable potassium range, resulting in false elevation results of patient samples when using Medica s capillary tubes.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
RAPIDPOINT®340/350 pH Electrode
Generic Name
Blood pH electrode
Model / Ref / Catalog
10375796
Primary DI / UDI-DI
00630414566245
510(k) Number
FDA Product Code
GKF, CEM, JFP, CHL, JGS
GMDN Term
Blood pH electrode
Device Class
Class II
Regulation Number
864.5600, 862.1600, 862.1145, 862.1120, 862.1665
GUDID distribution status
In Commercial Distribution

Related devices

Category: Blood pH electrode

Cleared under the same submission (K021515)

Show all (12)

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

  • Lot / Batch Number
  • Expiration Date

Other properties (12)

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