Identity
- Trade Name
- RAPIDLab® 348 6.8/7.3 Buffer Pack FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent FDA UDI
- Model / Reference
- 10309757 FDA UDI
- Description
- RAPIDLab® 348/348EX 6.8/7.3 Buffer Reagent FDA UDI
Identifiers
- Catalog Number
- 104227 FDA UDI
- Primary DI / UDI-DI
- 00630414053455 FDA UDI
- 510(k) Number
- K962021 FDA UDI
- FDA Product Code
- JFP FDA UDICGZ FDA UDICEM FDA UDICHL FDA UDIJGS FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1145 FDA UDI862.1170 FDA UDI862.1600 FDA UDI862.1120 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple blood gas analyte IVD, calibrator
RAPIDLab® 348 6.8/7.3 Buffer Pack 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, calibrator.
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Cleared under the same submission
K962021 also covers:
- RAPIDLab® 348 Wash — Siemens Healthcare Diagnostics
- RAPIDLab® 348/348EX HCT Slope — Siemens Healthcare Diagnostics
- RAPIDLab® Deproteinizer — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Hct Sensor — Siemens Healthcare Diagnostics
- Ready Sensor™ GOLD Reference Sensor Inner Element — 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 02da8916-c179-48e0-ab84-dbb4cd583966 37 fields · synced May 30, 2026