FDA Registration
Active
🇺🇸 United States
First Breath
Reg #: 3012307300
·
FEI: 3012307300
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ICU Medical, Inc.
- Registration Number
- 3012307300
- FEI Number
- 3012307300
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6000 Nathan Lane North
- City
- Minneapolis
- State
- MN
- ZIP
- 55442
- Country
- US
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 |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2003-09-15 |
Proprietary Names
First Breath
OXYGEN NASAL CANNULA
Portex Nasal Oxygen set (IFE)
Portex
AquinOx
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198