FDA Registration
Active
🇺🇸 United States
Pump Pouch, Cozmo Pump
Reg #: 3012307300
·
FEI: 3012307300
·
Expires 2025
Products
1
Proprietary Names
4
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
Regulatory Submissions
- 510(k) Number
- K020655
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 |
|---|---|---|---|---|---|
| Pump, Infusion, Insulin | LZG | Class 2 | General Hospital | No | 2008-02-25 |
Proprietary Names
Pump Pouch, Cozmo Pump
Travel Case, Cozmo Pump
Belt Clip, Cozmo Pump
Ir Adapter, Cozmo Pump
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198