Identity
- Trade Name
- PHOENIX DIAGNOSTICS, INC. FDA UDI
- Generic Name
- Sodium (Na+) electrode IVD FDA UDI
- Device Name
- Na+ Electrode for Roche / Hitachi Chemistry Systems FDA UDI
- Model / Reference
- E-300 FDA UDI
- Description
- Na+ Electrode for Roche / Hitachi Chemistry Systems FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853366007301 FDA UDI
- 510(k) Number
- K013451 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
No
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
Phoenix Diagnostics, Inc. by Phoenix Diagnostics, Inc. — 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
K013451 also covers:
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- PHOENIX DIAGNOSTICS, INC. — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI cf471160-bc5c-4e61-80f0-c1ee8ac4dae3 34 fields · synced Jun 1, 2026