Identity
- Trade Name
- RAPIDLab® 1200 Systems Reagent Cartridge FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
- Device Name
- RAPIDLab® 1200 Systems Reagent Cartridge for in vitro diagnostics use with the RAPIDLab 1200 series systems. FDA UDI
- Model / Reference
- 10319811 FDA UDI
- Description
- RAPIDLab® 1200 Systems Reagent Cartridge for in vitro diagnostics use with the RAPIDLab 1200 series systems. FDA UDI
Identifiers
- Catalog Number
- 3909458 FDA UDI
- Primary DI / UDI-DI
- 00630414492605 FDA UDI
- 510(k) Number
- K031560 FDA UDI
- FDA Product Code
- JGS FDA UDICGA FDA UDICHL FDA UDIKHP FDA UDIGKR FDA UDICEM FDA UDIJFP FDA UDICGZ FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1665 FDA UDI862.1345 FDA UDI862.1120 FDA UDI862.1450 FDA UDI864.5620 FDA UDI862.1600 FDA UDI862.1145 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent
RAPIDLab® 1200 Systems Reagent Cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 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 pCO2 — 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 c7a20de4-7d13-4f56-b1dd-01c504372a7c 37 fields · synced Jun 8, 2026