FDA Registration
Active
🇺🇸 United States
Cardinal Health
Reg #: 2183164
·
FEI: 1000116809
·
Expires 2026
Products
14
Proprietary Names
1
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- Cardinal Health
- Registration Number
- 2183164
- FEI Number
- 1000116809
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1313 WEST GRANT BLVD.
- City
- Wabasha
- State
- MN
- ZIP
- 55981
- Country
- US
Regulatory Submissions
- 510(k) Number
- K983097
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 |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-01-10 |
| Device, Iontophoresis, Other Uses | EGJ | Class 2 | Physical Medicine | No | 2008-11-20 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2008-01-10 |
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-12-04 |
| Bandage, Elastic | FQM | Class 1 | General Hospital | No | 2007-04-26 |
| Implanted Electrical Device Intended For Treatment Of Fecal Incontinence | QON | Class 3 | Gastroenterology, Urology | No | 2012-11-30 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2001-08-31 |
| Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence | NAM | Class 2 | Gastroenterology, Urology | No | 2013-07-09 |
| Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief | NHI | Class 2 | Neurology | No | 2019-03-14 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 1994-07-14 |
| Solvent, Adhesive Tape | KOX | Class 1 | General, Plastic Surgery | No | 2004-04-07 |
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2001-07-27 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2018-07-27 |
| Computer, Diagnostic, Programmable | DQK | Class 2 | Cardiovascular | No | 2013-01-11 |
Proprietary Names
AMPCARE E Series Electrodes
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)