Identity
- Trade Name
- RAPIDPoint® 405/500 Measurement Cartridge FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE) FDA UDI
- Device Name
- RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers. FDA UDI
- Model / Reference
- 10310469 FDA UDI
- Description
- RAPIDPoint® 405/500 Measurement Cartridge (750 tests) - pH, pCO2, pO2, Na+, Ca++, Cl-, K+, Glu, tHb, FO2Hb, FHHb, FCOHb, FMetHb, nBili is an in vitro diagnostics device which is intended to be used on the RAPIDPoint® 405/500 analyzers. FDA UDI
Identifiers
- Catalog Number
- 130522 FDA UDI
- Primary DI / UDI-DI
- 00630414477848 FDA UDI
- 510(k) Number
- K020616 FDA UDI
- FDA Product Code
- GKR FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5620 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE)
RAPIDPoint® 405/500 Measurement Cartridge by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple blood gas analyte IVD, kit, ion-selective electrode (ISE).
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Cleared under the same submission
K020616 also covers:
- RAPIDPoint® 400 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — Siemens Healthcare Diagnostics
- RAPIDPoint® 405/500 Measurement Cartridge — 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 9edffdb8-2709-41e5-b64a-aa8ba75b6518 37 fields · synced Jun 8, 2026