FDA Registration
Active
🇺🇸 United States
ICU Medical, Inc.
Reg #: 1824231
·
FEI: 1824231
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ICU Medical, Inc.
- Registration Number
- 1824231
- FEI Number
- 1824231
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5700 W 23rd Ave
- City
- Gary
- State
- IN
- ZIP
- 46406
- Country
- US
Regulatory Submissions
- 510(k) Number
- K954429
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 |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2013-04-30 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)