FDA Registration
Active
🇺🇸 United States
Portex L.O.R. Syringes with NRFit Connector
Reg #: 1217052
·
FEI: 1217052
·
Expires 2025
Products
4
Proprietary Names
5
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ICU Medical, Inc.
- Registration Number
- 1217052
- FEI Number
- 1217052
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 10 Bowman Dr
- City
- KEENE
- State
- NH
- ZIP
- 03431
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172410
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, Conduction, Anesthetic (W/Wo Introducer) | BSP | Class 2 | Anesthesiology | No | 2018-08-15 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2018-08-15 |
| Filter, Conduction, Anesthetic | BSN | Class 2 | Anesthesiology | No | 2018-08-15 |
| Needle, Spinal, Short Term | MIA | Class 2 | Anesthesiology | No | 2018-08-15 |
Proprietary Names
Portex L.O.R. Syringes with NRFit Connector
Portex EpiFuse Catheter with NRFit Connector
Portex Filter Straw with NRFit Connector
Portex Epidural Flat Filter with NRFit Connector
Portex Filter Needle with NRFit Connector
Establishment Types
Manufacture Medical Device