FDA Registration
Active
🇲🇽 Mexico
Clave Ext Set
Reg #: 9617594
·
FEI: 3003807466
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- ICU MEDICAL DE MEXICO, S. de R.L. de C.V.
- Registration Number
- 9617594
- FEI Number
- 3003807466
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Avenida Cuarzo No. 250, Colonia Rancho Santa Clara, Maneadero
- City
- ENSENADA, Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K941190
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 |
|---|---|---|---|---|---|
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2010-02-18 |
Proprietary Names
Clave Ext Set
Ext Set
IV Ext Set
CLAVE Extension Sets
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device