FDA Registration
Active
🇯🇵 Japan
Cardinal Health K.K.
Reg #: 3012341425
·
FEI: 3012341425
·
Expires 2026
Products
10
Proprietary Names
0
Establishment Types
1
Classifications
10
Registration Details
- Registration Name
- Cardinal Health K.K.
- Registration Number
- 3012341425
- FEI Number
- 3012341425
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3033 MOROI
- City
- FUKUROI Shizuoka
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K153316
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 |
|---|---|---|---|---|---|
| Surgeon'S Gloves | KGO | Class 1 | General, Plastic Surgery | No | 2016-05-23 |
| Medical Glove, Specialty | LZC | Class 1 | General Hospital | No | 2016-05-23 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 1999-08-04 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2010-10-18 |
| Needle, Suturing, Disposable | GAB | Class 1 | General, Plastic Surgery | No | 2009-07-08 |
| Bandage, Cast | ITG | Class 1 | Physical Medicine | No | 1999-08-04 |
| Pump, Infusion, Enteral | LZH | Class 2 | General Hospital | No | 2018-07-27 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2010-11-11 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | Class 2 | General Hospital | No | 2001-07-27 |
| Tubing, Noninvasive | GAZ | Class 2 | General Hospital | No | 2007-04-26 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device