Identity
- Trade Name
- Oracle Health Blood Bank FDA UDI
- Generic Name
- Blood bank information system application software FDA UDI
- Device Name
- Oracle Health Blood Bank EUDAMED
- Model / Reference
- 10000128 EUDAMEDPathNet Blood Bank Transfusion 2018 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00853023006173 EUDAMEDFDA UDI
- Basic UDI-DI
- 0085302300BBTS6 EUDAMED
- FDA Product Code
- MMH FDA UDI
- EMDN Code
- Z12040182 GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Blood bank information system application software FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9165 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Oracle Health Blood Bank by Cerner Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0085302300BBTS6 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cerner Corporation
- EUDAMED SRN
- US-MF-000007215
- Authorised Representative
- Oracle Nederland BV NL-AR-000038897
Sources (2)
- EUDAMED 60ec58d4-46c2-43a4-abd1-73a455aa3d0e 61 fields · synced Jul 21, 2026
- FDA UDI 458bed95-fb68-460d-bb3c-f4da94387076 33 fields · synced May 30, 2026