Identity
- Trade Name
- cobas b 221 S2 Fluid Pack FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, reagent FDA UDI
- Model / Reference
- 3260925184 FDA UDI
Identifiers
- Catalog Number
- 3260925184 FDA UDI
- Primary DI / UDI-DI
- 04015630028092 FDA UDI
- FDA Product Code
- CEM FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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, reagent
cobas b 221 S2 Fluid Pack by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple blood gas analyte IVD, reagent.
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- cobas b 221 GLU/LAC Cassette — Roche Diagnostics Corp. · Class I
- cobas b 221 S3 Fluid Pack — Roche Diagnostics Corp. · Class I
- cobas b 221 GLU Cassette — Roche Diagnostics Corp. · Class II
- cobas b 221 GLU/LAC/UREA (BUN) Cassette — Roche Diagnostics Corp. · Class II
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
- Roche Diagnostics Corp.
Sources (1)
- FDA UDI 60766d82-f772-4e58-91a4-a1dad0c226e4 34 fields · synced May 31, 2026