FDA Registration
Active
🇺🇸 United States
MALLINCKRODT HOSPITAL PRODUCTS, INC.
Reg #: 3009140376
·
FEI: 3009140376
·
Expires 2026
Products
5
Proprietary Names
4
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- MALLINCKRODT HOSPITAL PRODUCTS, INC.
- Registration Number
- 3009140376
- FEI Number
- 3009140376
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 675 McDonnell Blvd
- City
- Hazelwood
- State
- MO
- ZIP
- 63042
- Country
- US
Regulatory Submissions
- 510(k) Number
- K843640
Owner / Operator
- Firm Name
- Mallinckrodt Hospital Products, Inc
- Operator Number
- 1925021
- Address
- 6603 Femrite Drive
- City
- Madison
- State
- WI
- Postal Code
- 53718
- Country
- US
- Correspondent
- David Trueblood
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2016-10-19 |
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2007-11-15 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2012-12-05 |
| Shield, Vial | IWW | Class 1 | Radiology | No | 1992-12-01 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 1992-12-01 |
Proprietary Names
Recothrom
Xenotron I Xenon (Xe 133) Gas Dispenser
Shield, vial
Ultravent
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198