Identity
- Trade Name
- RAPIDLab® 1200 Series 1240 FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1240 can determine pH, pCO2, pO2 parameters FDA UDI
- Model / Reference
- 10321840 FDA UDI
- Description
- RAPIDLab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The 1240 can determine pH, pCO2, pO2 parameters FDA UDI
Identifiers
- Catalog Number
- 5060298 FDA UDI
- Primary DI / UDI-DI
- 00630414515540 FDA UDI
- 510(k) Number
- K031560 FDA UDI
- FDA Product Code
- CGZ FDA UDICHL FDA UDIGKR FDA UDICEM FDA UDIKHP FDA UDIJFP FDA UDICGA FDA UDIJGS FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1170 FDA UDI862.1120 FDA UDI864.5620 FDA UDI862.1600 FDA UDI862.1450 FDA UDI862.1145 FDA UDI862.1345 FDA UDI862.1665 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blood gas/haemoximetry analyser IVD, point-of-care
RAPIDLab® 1200 Series 1240 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 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 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 d47feade-a466-4180-b0b8-d1d49c9bb105 37 fields · synced Jun 1, 2026