WATERS MEDICAL SYSTEMS, LLC

FDA Device Registration & Listing · ROCHESTER, MN, US · Registration 2123774

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2123774
FEI Number
2123774
Entity Name
WATERS MEDICAL SYSTEMS, LLC
City/State/Country
ROCHESTER, MN, US
Establishment Address
2900 37th St NW, Building 003, ROCHESTER, MN 55901, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Waters Medical Systems LLC (Owner Number: 10024390)
Owner / Operator Contact Address
2900 37th St NW, Building 003, Rochester, MN 55901, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K221386
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2016-06-06
KDN System, Perfusion, Kidney Gastroenterology, Urology Class 2 876.5880 2022-10-31
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2022-10-31
KDL Set, Perfusion, Kidney, Disposable Gastroenterology, Urology Class 2 876.5880 2022-10-31

Official Correspondent

Ashley Banks

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Waters Medical Systems LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K013575 Organ Recovery Systems, Inc. KPS-I, THE KIDNEY PERFUSION SOLUTION 2002-01-25

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2123774. Last updated year: 2026. Please use registration number 2123774 when referencing this establishment in official correspondence.
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