Identity
- Trade Name
- TB3 K+/Ca++/Cl- Test/Blank Sensor FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
- Model / Reference
- 10311665 FDA UDI
- Description
- Blank sensor to replace the K+/Ca++/Cl-sensor. An in vitro medical device used on Siemens Healthcare Diagnostics RAPIDLab® Series systems. FDA UDI
Identifiers
- Catalog Number
- 673702 FDA UDI
- Primary DI / UDI-DI
- 00630414132075 FDA UDI
- 510(k) Number
- K934907 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood gas/haemoximetry analyser IVD, point-of-care
TB3 K+/Ca++/Cl- Test/Blank Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood gas/haemoximetry analyser IVD, point-of-care.
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- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
- STAT PROFILE — NOVA BIOMEDICAL CORPORATION · Class II
Cleared under the same submission
K934907 also covers:
- RL 1200 Waste Bottle Kit — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Calcium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Glucose Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- Ready Sensor™ Lactate Biosensor — Siemens Healthcare Diagnostics
- TB1 pO2/pCO2 Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB2 pH/Na+ Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB5 Ref Test/Blank 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (1)
- FDA UDI 9d6224a6-783f-45b5-8a4c-c8d021d510d4 36 fields · synced May 30, 2026