FDA Registration
Active
🇺🇸 United States
EDGE
Reg #: 1217052
·
FEI: 1217052
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ICU Medical, Inc.
- Registration Number
- 1217052
- FEI Number
- 1217052
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10 Bowman Dr
- City
- KEENE
- State
- NH
- ZIP
- 03431
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073188
Owner / Operator
- Firm Name
- ICU Medical, Inc.
- Operator Number
- 8020727
- Address
- 951 Calle Amanecer
- City
- San Clemente
- State
- CA
- Postal Code
- 92673
- Country
- US
- Correspondent
- Michelle Doherty
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2008-10-29 |
Proprietary Names
EDGE
Establishment Types
Manufacture Medical Device