FDA Registration
Active
🇺🇸 United States
NXSTAGE MEDICAL, INC.
Reg #: 3003464075
·
FEI: 3003464075
·
Expires 2026
Products
11
Proprietary Names
3
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- NXSTAGE MEDICAL, INC.
- Registration Number
- 3003464075
- FEI Number
- 3003464075
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 350 Merrimack St
- City
- LAWRENCE
- State
- MA
- ZIP
- 01843
- Country
- US
Regulatory Submissions
- 510(k) Number
- K971860
Owner / Operator
- Firm Name
- Fresenius Medical Care Holdings, Inc.
- Operator Number
- 10061218
- 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 |
|---|---|---|---|---|---|
| Accessories, Blood Circuit, Hemodialysis | KOC | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
| Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | KPO | Class 2 | Gastroenterology, Urology | No | 2019-09-20 |
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
| Warmer, Thermal, Infusion Fluid | LGZ | Class 2 | General Hospital | No | 2019-09-20 |
| Needle, Hypodermic, Single Lumen | FMI | Class 2 | General Hospital | No | 2019-09-25 |
| Needle, Fistula | FIE | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
| Protector, Transducer, Dialysis | FIB | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 2019-09-25 |
| Subsystem, Proportioning | FKR | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
| Separator, Automated, Blood Cell And Plasma, Therapeutic | LKN | Class U | Unknown | No | 2019-09-25 |
| Monitor, Temperature, Dialysis | FLA | Class 2 | Gastroenterology, Urology | No | 2019-09-25 |
Proprietary Names
ViraGuard Viral Blocking Patient Transducer Protector
NxStage Cartridge Express
VersiHD with GuideMe Software
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198