Identity
- Trade Name
- ISE Sodium electrode FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Device Name
- ISE Sodium Electrode for use with EasyElectrolyte Analyzers FDA UDI
- Model / Reference
- 5201 FDA UDI
- Description
- ISE Sodium Electrode for use with EasyElectrolyte Analyzers FDA UDI
Identifiers
- Catalog Number
- 5201 FDA UDI
- Primary DI / UDI-DI
- 00386100001636 FDA UDI
- 510(k) Number
- K000926 FDA UDI
- FDA Product Code
- JGS FDA UDI
- GMDN Term
- Sodium (Na+) electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Sodium (Na+) electrode IVD
ISE Sodium electrode by Medica Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sodium (Na+) electrode IVD.
- Sodium electrode — Roche Diagnostics Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- Sodium Electrode — Jeol · Class II
- I.S.E. NA — Randox Laboratories, Ltd. · Class II
- Sodium Electrode — Roche Diagnostics Corp. · Class II
- i-STAT — Abbott Point of Care Inc. · Class II
- ISE Sodium Electrode — Roche Diagnostics Corp. · Class II
- RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K000926 also covers:
- Chloride Electrode — Medica Corp.
- EasyElectrolyte Reagent Module, Na/K/Cl Analyzers — Medica Corp.
- ISE Chloride Electrode — Medica Corp.
- ISE Cleaning Solution Kit — Medica Corp.
- ISE Disposable Reference Electrode — Medica Corp.
- ISE Potassium Electrode — Medica Corp.
- ISE Reagent Module — Medica Corp.
- ISE Reagent Pack — Medica Corp.
- ISE eChloride Electrode — Medica Corp.
- Na/K/Cl Analyzer — Medica Corp.
- RAPIDChem® 700 Chloride Sensor — Siemens Healthcare Diagnostics
- RAPIDChem® 700 RAPIDPoint® 340/350 Reference Sensor — Siemens Healthcare Diagnostics
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medica Corp.
Sources (1)
- FDA UDI 007ac2f9-9f9b-4076-9732-5b84e2c9a66f 37 fields · synced May 30, 2026