FDA Registration
Active
🇺🇸 United States
Cerner Corporation
Reg #: 3013546957
·
FEI: 3013546957
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- Cerner Corporation
- Registration Number
- 3013546957
- FEI Number
- 3013546957
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 8779 Hillcrest Rd
- City
- Kansas City
- State
- MO
- ZIP
- 64138
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093134
Owner / Operator
- Firm Name
- Cerner Corporation
- Operator Number
- 9011113
- Address
- 8779 Hillcrest Road, --
- City
- Kansas City
- State
- MO
- Postal Code
- 64138
- Country
- US
- Correspondent
- Eri Gremi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2016-01-12 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2009-12-11 |
| Blood Establishment Computer Software And Accessories | MMH | Class 2 | Hematology | No | 2006-11-01 |
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2012-11-05 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2006-11-01 |
| System, Network And Communication, Physiological Monitors | MSX | Class 2 | Cardiovascular | No | 2016-02-24 |
Proprietary Names
Oracle Health Patient Observer
Cerner CareAware IBus
Oracle Health Blood Bank
Cerner FetaLink+
Oracle Health Transfusion Administration and Oracle Health Bridge Specimen Collection
Image Viewer
Oracle Health Event Management
FetaLink
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device