FDA Registration
Active
🇺🇸 United States
CareFusion 303, INC
Reg #: 3003879246
·
FEI: 3003879246
·
Expires 2026
Products
6
Proprietary Names
45
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- CareFusion 303, INC
- Registration Number
- 3003879246
- FEI Number
- 3003879246
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3750 Torrey View Ct
- City
- San Diego
- State
- CA
- ZIP
- 92130
- Country
- US
Regulatory Submissions
- 510(k) Number
- K043299
Owner / Operator
- Firm Name
- CareFusion 303, INC.
- Operator Number
- 9068764
- Address
- 3750 Torrey View Ct, --
- City
- San Diego
- State
- CA
- Postal Code
- 92130
- Country
- US
- Correspondent
- Darin Oppenheimer
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion, Pca | MEA | Class 2 | General Hospital | No | 2007-11-20 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2025-09-04 |
| Infusion Safety Management Software | PHC | Class 2 | General Hospital | No | 2025-09-04 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2025-09-04 |
| Cabinet, Table And Tray, Anesthesia | BRY | Class 1 | Anesthesiology | No | 2007-09-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2007-11-20 |
Proprietary Names
Alaris PCA
BD Alaris Auto-ID Module
BD Alaris PC Unit
BD Alaris Pump Module, Model 8100
BD Alaris Calculation Services, Software
BD Alaris System Maintenance Software
BD Alaris PCU Module, Model 8015, Software
BD Alaris PCU Module, Model 8015
Alaris System Maintenance Software
Alaris Guardrails Editor Software
BD Alaris Infusion Adapter Software
BD Alaris ETCO2 Module, Model 8300
BD Alaris Syringe Module, Model 8110, Software
Alaris PCA Module, Model 8120, Software
BD Alaris System with Guardrails Suite MX
BD Alaris ETC02 Module, Model 8300, Software
BD Alaris Pump Module, Model 8100, Software
BD Alaris Syringe Module, Model 8110
Alaris PC Unit
BD Pyxis Anesthesia Station ES
BD Pyxis MedStation 4000
BD Pyxis MedBank Tower
BD Pyxis Medflex 2000
BD Pyxis MedStation ES Tower
BD Pyxis MedBank Tower Auxiliary
BD Pyxis Medflex 1000
BD Pyxis MedStation ES
BD Pyxis Med Auxiliary (AUX)
BD Pyxis Med Auxiliary (AUX) Tower
BD Pyxis MedBank Mini
BD Pyxis Anesthesia Station 4000
BD Pyxis MedBank Mini Auxiliary
BD Pyxis ES Refrigerator
BD Pyxis Pro MedStation Dispensing System
BD Pyxis MedStation 4000 Integrated Main
BD Pyxis MedBank CUBIE Replenishment Station
BD Pyxis CUBIE System
BD Pyxis Enterprise Server
Alaris/Medley SpO2 Module
BD Alaris System Manager 9601, Software
BD Alaris ETC02 Module, Model 8300
Alaris PCA Module, Model 8120
BD Alaris System with Guardrails Suite Software
Alaris Auto-ID Module
Alaris/Medley EtCO2 Module
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device