RAPIDPOINT®340/350 Ph Electrode
RAPIDPOINT® 340/350 pH Electrode for use with Rapidpoint® 340/350 Analyzers.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | GKF |
| Device type | Instrument, Hematocrit, Automated |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5600 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K021515 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Close container tightly before air shipment; Storage environment temperature 5 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10375796 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 2 |
| RAPIDPoint® 400 Measurement Cartridge | Siemens Healthcare Diagnostics Inc | 1 |
| UltraChek Reference Controls Low | Separation Technology, Inc. | 1 |
| Rapidpoint® 340/350 Valve Module | Siemens Healthcare Diagnostics Inc | 1 |
| UltraCrit (Refurbished) | Separation Technology, Inc. | 1 |
| UltraCrit Cuvettes | Separation Technology, Inc. | 1 |
| RAPIDSystems™ AutomaticQC Cartridge | Siemens Healthcare Diagnostics Inc | 1 |
| UltraChek Reference Controls High | Separation Technology, Inc. | 1 |
| UltraCrit Loaner | Separation Technology, Inc. | 1 |
| UltraCrit QC Cuvettes | Separation Technology, Inc. | 1 |
| UltraCrit | Separation Technology, Inc. | 1 |
| UltraChek Reference Controls Normal | Separation Technology, Inc. | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medica Corp. | 510(k) number | 2025-12-31 | Class II | Nonconforming Material/Component | 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. | 1,578 units |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.