FDA Registration
Active
🇺🇸 United States
MAHURKAR Acute Triple Lumen Catheter Kits and Trays
Reg #: 3007544634
·
FEI: 3007544634
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Paragon Medical - Mansfield
- Registration Number
- 3007544634
- FEI Number
- 3007544634
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 111 Forbes Blvd Suite 101
- City
- Mansfield
- State
- MA
- ZIP
- 02048
- Country
- US
Regulatory Submissions
- 510(k) Number
- K020089
Owner / Operator
- Firm Name
- PARAGON MEDICAL, INC.
- Operator Number
- 10041165
- Address
- 8 Matchett Drive
- City
- Pierceton
- State
- IN
- Postal Code
- 46562
- Country
- US
- Correspondent
- Jim F Rogers
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Hemodialysis, Triple Lumen, Non-Implanted | NIE | Class 2 | Gastroenterology, Urology | No | 2014-04-22 |
Proprietary Names
MAHURKAR Acute Triple Lumen Catheter Kits and Trays
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)