FDA Registration
Active
🇺🇸 United States
The Monarch safety Blood Collection Set
Reg #: 3030243919
·
FEI: 3030243919
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- THE MONARCH COMPANY, LLC
- Registration Number
- 3030243919
- FEI Number
- 3030243919
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2700 Corporate Dr Ste 200
- City
- Birmingham
- State
- AL
- ZIP
- 35242
- Country
- US
Regulatory Submissions
- 510(k) Number
- K232308
Owner / Operator
- Firm Name
- The Monarch company, LLC
- Operator Number
- 10089652
- Address
- 4000 Eagle Point Corporate Drive
- City
- Birmingham
- State
- AL
- Postal Code
- 35242
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2023-12-26 |
Proprietary Names
The Monarch safety Blood Collection Set
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198