FDA Registration
Active
🇺🇸 United States
Cook® Spectrum® Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen
Reg #: 1820334
·
FEI: 1820334
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Cook Incorporated
- Registration Number
- 1820334
- FEI Number
- 1820334
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- ZIP
- 47404
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081113
Owner / Operator
- Firm Name
- COOK, INC.
- Operator Number
- 1820334
- Address
- 750 DANIELS WAY
- City
- Bloomington
- State
- IN
- Postal Code
- 47404
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | Class 2 | General Hospital | No | 2012-01-25 |
Proprietary Names
Cook® Spectrum® Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated Power Injectable Triple Lumen
Cook Spectrum Central Venous Catheter Tray Power Injectable Double Lumen Minocycline/Rifampin Antibiotic Impregnated
Spectrum Central Venous Catheter Set Triple Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated
Spectrum Central Venous Tray Triple Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated
Spectrum Central Venous Tray Five Lumen Polyurethane Catheter Minocycline/Rifampin Impregnated
Cook Spectrum Central Venous Catheter Tray Power Injectable Triple Lumen Minocycline/Rifampin Antibiotic Impregnated
Spectrum Central Venous Catheter Set Double Lumen Polyurethane Minocycline/Rifampin Antibiotic Impregnated
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device