FDA Registration
Active
🇨🇷 Costa Rica
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad
Reg #: 9615050
·
FEI: 3002999813
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ICU Medical Costa Rica Ltd.
- Registration Number
- 9615050
- FEI Number
- 3002999813
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Km Noreste del Centro Comercial Real Cariari, ZONA FRANCA GLOBAL Park
- City
- La Aurora de Heredia
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K170982
Owner / Operator
- Firm Name
- ICU MEDICAL, INC.
- Operator Number
- 2025816
- Address
- 951 Calle Amanecer, --
- City
- San Clemente
- State
- CA
- Postal Code
- 92673
- Country
- US
- Correspondent
- Michelle Doherty
US Agent
- Business Name
- ICU MEDICAL, INC.
- Contact Name
- Michelle Doherty
- Address
- 951 Calle Amanecer
- City
- San Clemente
- State
- CA
- ZIP
- 92673
- Country
- US
- [email protected]
- Phone
- 949 3706562
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Neuraxial Administration Set - Intrathecal Delivery | PYR | Class 2 | General Hospital | No | 2023-12-04 |
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2023-12-04 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2023-12-04 |
| Accessories, Pump, Infusion | MRZ | Class 2 | General Hospital | No | 2023-12-04 |
Proprietary Names
CADD®- Solis Ambulatory Infusion Pump with Wireless Communication; CADD®-Solis Infusion Pump, Model 2110; PharmGuard® Ad
Establishment Types
Manufacture Medical Device