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Bicarbonate Calibrator
EUDAMEDFDA UDIFDA 510(k)Class B (EU MDR)
Ref ODC0019510(k) K141374Ref OSR6190
Identity
- Trade Name
- Bicarbonate Calibrator EUDAMEDBicarbonate EUDAMEDAU FDA UDI
- Generic Name
- Bicarbonate (HCO3-) IVD, calibrator FDA UDI
- Device Name
- Bicarbonate Calibrator EUDAMEDFDA UDIBicarbonate EUDAMED
- Model / Reference
- ODC0019 EUDAMEDFDA UDIOSR6190 EUDAMED
- Description
- BICARBONATE CALIBRATOR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590070441 EUDAMEDFDA UDI15099590010867 EUDAMED
- Basic UDI-DI
- 150995902ODC001994 EUDAMED150995902OSR6190MZ EUDAMED
- 510(k) Number
- K141374 FDA UDI
- FDA Product Code
- JIT FDA UDI
- EMDN Code
- W0101050399 CALIBRATORS AND STANDARDS (CLINICAL CHEMISTRY) - OTHER EUDAMEDW01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Bicarbonate (HCO3-) IVD, calibrator FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1150 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMEDEUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMEDEUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Bicarbonate Calibrator by Beckman Coulter Ireland Inc. — Class B — FDA_510K, IVDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141374 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 150995902ODC001994 | Class B | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
- FDA Applicant
- Beckman Coulter Ireland, Inc.
Sources (4)
- EUDAMED 7ac3dffa-b499-4928-b401-90f673adcd0a 85 fields · synced Oct 6, 2026
- FDA UDI ea5b658e-25ee-4166-af5b-58793558cf1c 34 fields · synced May 30, 2026
- EUDAMED ec4b53f8-7cdf-485a-a788-dfd2d0588ca8 61 fields · synced Jul 11, 2026
- FDA 510(k) K141374 1 fields · synced May 18, 2026