Identity
- Trade Name
- Ready Sensor™ GOLD Electrode pCO2 FDA UDI
- Generic Name
- Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- Ready Sensor™ pCO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments FDA UDI
- Model / Reference
- 10321857 FDA UDI
- Description
- Ready Sensor™ pCO2 Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments FDA UDI
Identifiers
- Catalog Number
- 5065729 FDA UDI
- Primary DI / UDI-DI
- 00630414492667 FDA UDI
- 510(k) Number
- K031560 FDA UDI
- FDA Product Code
- CEM FDA UDICHL FDA UDIJFP FDA UDIKHP FDA UDIJGS FDA UDIGKR FDA UDICGA FDA UDICGZ FDA UDI
- GMDN Term
- Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI862.1120 FDA UDI862.1145 FDA UDI862.1450 FDA UDI862.1665 FDA UDI864.5620 FDA UDI862.1345 FDA UDI862.1170 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: Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE)
Ready Sensor™ GOLD Electrode pCO2 by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Carbon dioxide (CO2) IVD, kit, ion-selective electrode (ISE).
- Carbon Dioxide Electrode — ELITECHGROUP INC. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® C02 Acid Reagent 88812 — Carolina Liquid Chemistries Corp. · Class II
- CAROLINA LIQUID CHEMISTRIES CORP.® C02 ALK Buffer 88813 — Carolina Liquid Chemistries Corp. · Class II
- Reference Electrode — VITALSCIENTIFIC
- Ready Sensor™ Gold pCO2 Sensor — Siemens Healthcare Diagnostics · Class II
- RAPIDPOINT®340/350 pCO2 Electrode — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
K031560 also covers:
- RAPIDLab® 1200 Na+/K+/Ca++/CL- Electrode Fill — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1240 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1245 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1260 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series 1265 — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Series CO-ox Sample Chamber — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Systems Reagent Cartridge — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 Systems Wash Cartridge — Siemens Healthcare Diagnostics
- RAPIDLab® 1200 pH Electrode Fill — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Calcium Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Chloride Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Electrode pO2 — 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 bd797ee8-e25f-4758-88cb-364755441c47 37 fields · synced May 30, 2026