FDA Registration
Active
🇺🇸 United States
Cardinal Health
Reg #: 1219103
·
FEI: 1000148701
·
Expires 2026
Products
18
Proprietary Names
0
Establishment Types
4
Classifications
18
Registration Details
- Registration Name
- Cardinal Health
- Registration Number
- 1219103
- FEI Number
- 1000148701
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2 Ludlow Park Dr
- City
- CHICOPEE
- State
- MA
- ZIP
- 01022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K952945
- PMA Number
- P190007
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, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2014-12-04 |
| Stimulator, Nerve, Peripheral, Electric | KOI | Class 2 | Anesthesiology | No | 2018-08-09 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | Class 1 | General, Plastic Surgery | No | 2008-01-10 |
| Cover, Shoe, Operating-Room | FXP | Class 1 | General, Plastic Surgery | No | 1999-08-04 |
| Fiber, Medical, Absorbent | FRL | Class 1 | General Hospital | No | 1999-08-04 |
| Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic | MGQ | Class U | Unknown | No | 2008-01-10 |
| Latex Patient Examination Glove | LYY | Class 1 | General Hospital | No | 2008-01-11 |
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2013-08-08 |
| Electrode, Electrocardiograph, Multi-Function | MLN | Class 2 | Cardiovascular | No | 2013-08-08 |
| Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | DRO | Class 2 | Cardiovascular | No | 2004-06-01 |
| Nursing Pad, Hydrogel | NTC | Class 1 | General Hospital | No | 2014-11-06 |
| Recorder, Paper Chart | DSF | Class 1 | Cardiovascular | No | 1996-12-16 |
| Container, I.V. | KPE | Class 2 | General Hospital | No | 2008-01-11 |
| Spill Kit | PXG | Class 1 | General Hospital | No | 2018-06-06 |
| Blood And Urine Collection Kit (Excludes Hiv Testing) | OIB | Class 1 | Pathology | No | 2011-11-09 |
| Polymer Patient Examination Glove | LZA | Class 1 | General Hospital | No | 2008-01-11 |
| Dressing, Wound, Drug | FRO | Class U | Unknown | No | 2008-01-10 |
| Electrode, Circular (Spiral), Scalp And Applicator | HGP | Class 2 | Obstetrics/Gynecology | No | 2008-01-11 |
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only