FDA Registration
Active
🇺🇸 United States
CADD-Solis Ambulatory Infusion Pump
Reg #: 2183161
·
FEI: 2183161
·
Expires 2025
Products
4
Proprietary Names
4
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ICU Medical, Inc.
- Registration Number
- 2183161
- FEI Number
- 2183161
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3350 Granada Avenue North
- City
- Oakdale
- State
- MN
- ZIP
- 55128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K170982
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 |
|---|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2017-08-30 |
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2017-08-30 |
| Neuraxial Administration Set - Intrathecal Delivery | PYR | Class 2 | General Hospital | No | 2017-08-30 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-08-30 |
Proprietary Names
CADD-Solis Ambulatory Infusion Pump
CADD-Administration Sets
Wireless Communication Module (CM)
PharmGuard Administrator Medication Safety Software
Establishment Types
Manufacture Medical Device