FDA Registration
Active
🇺🇸 United States
CLAVE Vial Access Spike
Reg #: 2025816
·
FEI: 2025816
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ICU MEDICAL, INC.
- Registration Number
- 2025816
- FEI Number
- 2025816
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 951 CALLE AMANECER
- City
- SAN CLEMENTE
- State
- CA
- ZIP
- 92673
- Country
- US
Regulatory Submissions
- 510(k) Number
- K934591
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2010-02-18 |
Proprietary Names
CLAVE Vial Access Spike
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility