FDA Registration
Active
🇺🇸 United States
Portex®Spinal Needles
Reg #: 3012307300
·
FEI: 3012307300
·
Expires 2025
Products
1
Proprietary Names
1
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
- K983858
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 |
|---|---|---|---|---|---|
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2007-01-04 |
Proprietary Names
Portex®Spinal Needles
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198