FDA Registration
Active
🇺🇸 United States
WATERS MEDICAL SYSTEMS, LLC
Reg #: 2123774
·
FEI: 2123774
·
Expires 2026
Products
5
Proprietary Names
14
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- WATERS MEDICAL SYSTEMS, LLC
- Registration Number
- 2123774
- FEI Number
- 2123774
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 2900 37th St NW, Building 003
- City
- ROCHESTER
- State
- MN
- ZIP
- 55901
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080432
Owner / Operator
- Firm Name
- Waters Medical Systems LLC
- Operator Number
- 10024390
- Address
- 2900 37th St NW, Building 003
- City
- Rochester
- State
- MN
- Postal Code
- 55901
- Country
- US
- Correspondent
- Ashley Banks
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Perfusion, Kidney | KDN | Class 2 | Gastroenterology, Urology | No | 2016-06-06 |
| Set, Perfusion, Kidney, Disposable | KDL | Class 2 | Gastroenterology, Urology | No | 2022-10-31 |
| System And Accessories, Isolated Heart, Transport And Preservation | MSB | Class 2 | Gastroenterology, Urology | No | 2014-12-04 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2013-08-13 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2016-06-06 |
Proprietary Names
PPS
Waters IGL Cold Storage Solution (CSS)
BEL-GEN Cold Storage Solution
Waters IGL Pulsatile Perfusion Solution (PPS)
PERF-GEN Pulsatile Perfusion Solution
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS
RM3 Renal Preservation Machine
Oxicom 3000
Oxicom 2100
Oxicom Liquid Control
RM4 Kidney Perfusion System
CSS
CoStorSol
WAVES
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device