Identity
- Trade Name
- RAPIDPOINT® 340/350 Valve Module FDA UDI
- Generic Name
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
- Device Name
- to be used on the RAPIDPOINT ® 340/350 FDA UDI
- Model / Reference
- 10376971 FDA UDI
- Description
- to be used on the RAPIDPOINT ® 340/350 FDA UDI
Identifiers
- Catalog Number
- 10376971 FDA UDI
- Primary DI / UDI-DI
- 00630414566788 FDA UDI
- FDA Product Code
- GKF FDA UDICHL FDA UDICGZ FDA UDICEM FDA UDIJGS FDA UDIJFP FDA UDI
- GMDN Term
- Blood gas/haemoximetry analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5600 FDA UDI862.1120 FDA UDI862.1170 FDA UDI862.1600 FDA UDI862.1665 FDA UDI862.1145 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
RAPIDPOINT® 340/350 Valve Module by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 bb7a1329-0c53-460d-9e41-de5a266c3791 35 fields · synced May 30, 2026