FDA Registration
Active
🇺🇸 United States
ICU MEDICAL, INC.
Reg #: 2024064
·
FEI: 2024064
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- ICU MEDICAL, INC.
- Registration Number
- 2024064
- FEI Number
- 2024064
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 13520 EVENING CREEK DRIVE NORTH, SUITE 200
- City
- SAN DIEGO
- State
- CA
- ZIP
- 92128
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242115
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-04-07 |
| Infusion Safety Management Software | PHC | Class 2 | General Hospital | No | 2025-04-07 |
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2017-02-17 |
| Set, Administration, Intravascular | FPA | Class 2 | General Hospital | No | 2017-02-17 |
Proprietary Names
Plum Duo Precision IV Pump
ICU Medical MedNet Medication Management Suite
LifeShield Infusion Safety Software Suite
PLUM XL Infusion System
Lifecare PCA Infusion system
Lifecare 5000 Infusion System
PLUM 360 Infusion System
Plum DuoTM Infusion System
PLUM A+ Infusion System
Infusion System
Plum Solo Precision IV Pump
Lifecare PCA Infusion System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device