FDA Registration
Active
🇺🇸 United States
IRADIMED CORPORATION
Reg #: 3005053560
·
FEI: 3005053560
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- IRADIMED CORPORATION
- Registration Number
- 3005053560
- FEI Number
- 3005053560
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 12705 Ingenuity Dr
- City
- Orlando
- State
- FL
- ZIP
- 32826
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090087
Owner / Operator
- Firm Name
- IRADIMED CORPORATION
- Operator Number
- 9070201
- Address
- 12705 Ingenuity Dr., --
- City
- Orlando
- State
- FL
- Postal Code
- 32826
- 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 | 2009-12-28 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2017-11-13 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2005-04-11 |
| Set, I.V. Fluid Transfer | LHI | Class 2 | General Hospital | No | 2026-05-05 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2017-11-13 |
Proprietary Names
MRidium 3860 MRI Infusion Pump System
3880 MRI Patient Monitoring System
MRidium IV Pole
MRidium 3870 MRI Infusion Pump System
1000 Series IV Sets
1119 MRI IV Pole
Mridium 3860+ MRI Infusion Pump/ Monitoring System
Hextrode MRI ECG Electrode
MRidium 3850 MRI Infusion Pump System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility