Identity
- Trade Name
- Sodium Electrode FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Model / Reference
- 21029371001 FDA UDI
Identifiers
- Catalog Number
- 21029371001 FDA UDI
- Primary DI / UDI-DI
- 04015630032457 FDA UDI
- 510(k) Number
- K963627 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
Yes
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
No
FDA UDI
Category: Sodium (Na+) electrode IVD
Sodium Electrode by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Sodium (Na+) electrode IVD.
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- RAPIDChem® 700 RAPIDPoint® 350 Sodium Sensor — Siemens Healthcare Diagnostics · Class II
- Ready Sensor™ GOLD Sodium Sensor — Siemens Healthcare Diagnostics · Class II
- ISE Sodium Electrode — STANBIO LABORATORY, L.P. · Class II
- Na (Sodium) Electrode — TOKYO BOEKI MEDISYS INC. · Class II
Cleared under the same submission
K963627 also covers:
- Chloride Electrode — Roche Diagnostics Corp.
- ISE Potassium Electrode — Roche Diagnostics Corp.
- ISE Solution 1 — Roche Diagnostics Corp.
- ISE Solution 2 — Roche Diagnostics Corp.
- ISE Solution 3 — Roche Diagnostics Corp.
- ISE Standard High — Roche Diagnostics Corp.
- ISE Standard Low — Roche Diagnostics Corp.
- Lithium Electrode — Roche Diagnostics Corp.
- Potassium Electrode — Roche Diagnostics Corp.
- no MS ISE Calibrator Direct) — Roche Diagnostics Corp.
- no MS ISE Calibrator IndirectUrine) — Roche Diagnostics Corp.
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 69e9bb08-879f-4a05-8523-19bfe29b0114 35 fields · synced Jun 6, 2026