FDA Registration
Active
🇺🇸 United States
MRidium 3850 MRI Infusion Pump System
Reg #: 3005053560
·
FEI: 3005053560
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- IRADIMED CORPORATION
- Registration Number
- 3005053560
- FEI Number
- 3005053560
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1025 Willa Springs Dr
- City
- Winter Springs
- State
- FL
- ZIP
- 32708
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050301
Owner / Operator
- Firm Name
- IRADIMED CORPORATION
- Operator Number
- 9070201
- Address
- 1025 WILLA SPRINGS DRIVE, --
- City
- Winter Springs
- State
- FL
- Postal Code
- 32708
- Country
- US
- Correspondent
- Daniel L Bennett
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2008-02-21 |
Proprietary Names
MRidium 3850 MRI Infusion Pump System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device