Identity
- Trade Name
- TB1 pO2/pCO2 Test/Blank Sensor FDA UDI
- Generic Name
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments FDA UDI
- Model / Reference
- 10316620 FDA UDI
- Description
- Test/Blank Sensor in vitro diagnostics device to replace the pO2/pCO2 sensors on the 1200 series instruments FDA UDI
Identifiers
- Catalog Number
- 2195443 FDA UDI
- Primary DI / UDI-DI
- 00630414515250 FDA UDI
- FDA Product Code
- CHL FDA UDI
- GMDN Term
- Multiple electrolyte IVD, kit, ion-selective electrode (ISE) 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: Multiple electrolyte IVD, kit, ion-selective electrode (ISE)
TB1 pO2/pCO2 Test/Blank Sensor by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple electrolyte IVD, kit, ion-selective electrode (ISE).
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC.
- CLC720 Chemistry Analyzer w/ISE — Carolina Liquid Chemistries Corp. · Class I
- CLC1600 Chemistry Analyzer with ISE Module — Carolina Liquid Chemistries Corp. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- Pointe Scientific, Inc. — POINTE SCIENTIFIC, INC. · Class II
- SelectaLyte (Chloride Electrode) — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- SelectaLyte (Sodium Electrode) — AWARENESS TECHNOLOGY, INCORPORATED · Class II
- CLC800 Chemistry Analyzer with ISE Module — Carolina Liquid Chemistries Corp. · Class II
Cleared under the same submission
K002738 also covers:
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 400/405/500 Wash/Waste Cartridge — Siemens Healthcare Diagnostics
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics
- RAPIDSystems™ AutomaticQC Cartridge — Siemens Healthcare Diagnostics
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
- TB2 pH/Na+ Test/Blank Sensor — Siemens Healthcare Diagnostics
- TB3 K+/Ca++/Cl- 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 648ae977-f4ef-4631-8a78-85bb250272bf 36 fields · synced Jun 1, 2026