Identity
- Trade Name
- RAPIDPOINT® 350 Ca++ Electrode FDA UDI
- Generic Name
- Calcium (Ca2+) electrode IVD FDA UDI
- Device Name
- RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer FDA UDI
- Model / Reference
- 10376547 FDA UDI
- Description
- RAPIDPOINT® 350 Calcium Electrode, for use with RapidPoint® 350 analyzer FDA UDI
Identifiers
- Catalog Number
- 10376547 FDA UDI
- Primary DI / UDI-DI
- 00630414566771 FDA UDI
- 510(k) Number
- K021515 FDA UDI
- FDA Product Code
- CHL FDA UDIGKF FDA UDIJGS FDA UDIJFP FDA UDICEM FDA UDI
- GMDN Term
- Calcium (Ca2+) electrode IVD FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI864.5600 FDA UDI862.1665 FDA UDI862.1145 FDA UDI862.1600 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: Calcium (Ca2+) electrode IVD
RAPIDPOINT® 350 Ca++ Electrode by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Calcium (Ca2+) electrode IVD.
Cleared under the same submission
K021515 also covers:
- Bi-Level QC Kit, HCT — Medica Corp.
- Calcium Electrode — Medica Corp.
- Daily Cleaning Solution Kit — Medica Corp.
- Potassium Electrode — Medica Corp.
- Reagent Module — Medica Corp.
- Sodium Electrode — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- pH/pCO2/pO2/Na/K/Ca Analyzer — Medica Corp.
- RAPIDChem® 700, RAPIDPoint® 340 Trouble shooting kit — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Reagent Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sampler Module — Siemens Healthcare Diagnostics
- RAPIDPOINT® 340 Sensor Module — 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
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI bd7f29b5-1f61-465d-8ead-44e64ea6af7a 37 fields · synced May 30, 2026