FDA Registration
Active
🇨🇷 Costa Rica
Cardinal Health Costa Rica, S.A.
Reg #: 3009211636
·
FEI: 3009211636
·
Expires 2026
Products
27
Proprietary Names
0
Establishment Types
4
Classifications
27
Registration Details
- Registration Name
- Cardinal Health Costa Rica, S.A.
- Registration Number
- 3009211636
- FEI Number
- 3009211636
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Edificio B20 Calle #2 Zona Franca Coyol
- City
- -- Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K781357
Owner / Operator
- Firm Name
- Cardinal Health 200, LLC
- Operator Number
- 9028292
- Address
- 3651 Birchwood Drive, --
- City
- Waukegan
- State
- IL
- Postal Code
- 60085
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-12-18 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2018-07-27 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2023-01-24 |
| Catheter, Umbilical Artery | FOS | Class 2 | General Hospital | No | 2008-01-10 |
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2022-03-21 |
| Catheter, Hemodialysis, Non-Implanted | MPB | Class 2 | Gastroenterology, Urology | No | 2022-03-21 |
| Catheter, Peritoneal, Long-Term Indwelling | FJS | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Catheter, Hemodialysis, Implanted | MSD | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Catheter, Peritoneal Dialysis, Single Use | FKO | Class 2 | Gastroenterology, Urology | No | 2018-08-02 |
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2018-07-27 |
| Kit, Repair, Catheter, Hemodialysis | NFK | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2019-06-17 |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2018-07-27 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2008-01-17 |
| Catheter, Hemodialysis, Implanted, Coated | NYU | Class 2 | Gastroenterology, Urology | No | 2018-07-27 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2014-05-05 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1999-08-04 |
| Peripheral Catheter Insertion Kit | OWL | Class 2 | General Hospital | No | 2011-11-11 |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | Class 2 | Cardiovascular | No | 2018-07-27 |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | Class 2 | General Hospital | No | 2014-09-16 |
| Stylet, Catheter | DRB | Class 2 | Cardiovascular | No | 2022-03-21 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2013-04-12 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2025-05-21 |
| Dialysis Administration Kit | PEV | Class 2 | Gastroenterology, Urology | No | 2015-06-04 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2005-04-13 |
| Stopcock, I.V. Set | FMG | Class 2 | General Hospital | No | 2022-11-11 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2005-04-06 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device