FDA Registration
Active
🇺🇸 United States
5008X Hemodialysis System
Reg #: 3005162618
·
FEI: 1527681
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Fresenius USA Manufacturing, Inc.
- Registration Number
- 3005162618
- FEI Number
- 1527681
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 750 North Lallendorf Rd
- City
- OREGON
- State
- OH
- ZIP
- 43616
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231534
Owner / Operator
- Firm Name
- Fresenius Medical Care North America
- Operator Number
- 9030510
- Address
- 920 WINTER STREET, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
- Correspondent
- Rachel Lloyd
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2024-03-01 |
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2024-03-01 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2024-03-01 |
| Disinfectant, Dialysate Delivery System | NII | Class 2 | Gastroenterology, Urology | No | 2024-03-01 |
Proprietary Names
5008X Hemodialysis System
Establishment Types
Manufacture Medical Device