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Sign in to claim this brandWaters Medical Systems, LLC
US
Last updated September 17, 2026
About
Waters Medical Systems empowers transplant teams to improve transplant success and graft survival rates—enhancing patients’ lives.
From the manufacturer's own website. Source
Information
- Country
- US
- Address
- 2900 37th St NW, ROCHESTER, MN, 55901
- Website
- wtrs.com/
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2123774
- DUNS Number
- —
Catalogue (61)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CANNULA 12MM TEFLON STERILE - 1/packaging | CANNULA 12MM TEFLON STERILE | FDA UDI | Class II | Active |
| CANNULA 5MM TEFLON STERILE - 1/packaging | CANNULA 5MM TEFLON STERILE | FDA UDI | Class II | Active |
| RM3 Filter | RM3 Filter | FDA UDI | Class II | Active |
| Cannula 6mm SS, Non-Sterile | 6mm SS | FDA UDI | Class II | Active |
| Cannula 3mm SS, Non-Sterile | 3mm SS | FDA UDI | Class II | Active |
| Cannula 12mm SS, Non-Sterile | 12mm SS | FDA UDI | Class II | Active |
| WCM Kit | WCM Kit | FDA UDI | Class II | Unknown |
| RM3 Accessory - Filter/Adapter | RM3 Accessory - Filter/Adapter | FDA UDI | Class II | Active |
| CONTROL LIQUID, OXICOM - Low vial | CONTROL LIQUID, OXICOM - Low vial | FDA UDI | Class II | Active |
| CANNULA 13MM TEFLON STERILE - 1/packaging | CANNULA 13MM TEFLON STERILE | FDA UDI | Class II | Active |
| CONTROL LIQUID, OXICOM - Medium vial | CONTROL LIQUID, OXICOM - Medium vial | FDA UDI | Class II | Active |
| Cannula 4mm SS, Non-Sterile | 4mm SS | FDA UDI | Class II | Active |
| CANNULA 11MM TEFLON STERILE - 1/packaging | CANNULA 11MM TEFLON STERILE | FDA UDI | Class II | Active |
| CANNULA 3MM TEFLON STERILE - 1/packaging | CANNULA 3MM TEFLON STERILE | FDA UDI | Class II | Active |
| Cannula 11mm SS, Non-Sterile | 11mm SS | FDA UDI | Class II | Active |
| Cannula 14mm SS, Non-Sterile | 14mm SS | FDA UDI | Class II | Active |
| CUVETTES DC-80 Box 100 cuvettes - Plugs | DC-80 Cuvette Plugs | FDA UDI | Class II | Active |
| DCM100 Training Cassette - Non Sterile | DCM100 | FDA UDI | Class II | Active |
| CONTROL LIQUID, OXICOM - High vial | CONTROL LIQUID, OXICOM - High vial | FDA UDI | Class II | Active |
| Oxicom 3000 Oximeter | Oxicom 3000 | FDA UDI | Class II | Unknown |
| RM3 Accessory - Adapter | RM3 Filter Adapter | FDA UDI | Class II | Active |
| Oxicom 2100 Box Kit | Oxicom 2100 Kit | FDA UDI | N/A | Unknown |
| CUVETTES DC-80 Box 100 cuvettes & 100 plugs | Cuvette/Plug Kit | FDA UDI | Class II | Active |
| CANNULA 10MM TEFLON STERILE - 1/packaging | CANNULA 10MM TEFLON STERILE | FDA UDI | Class II | Active |
| CANNULA 4MM TEFLON STERILE - 1/packaging | CANNULA 4MM TEFLON STERILE | FDA UDI | Class II | Active |
| WAVES Transport Bag | WAVES Transport Bag | FDA UDI | Class II | Unknown |
| WCM Training Cassette - Non Sterile | WCM | FDA UDI | Class II | Unknown |
| Waves Control Unit | WAVES CONTROL UNIT | FDA UDI | Class II | Unknown |
| Rm3 Renal Perfusion Monitor | RM3 | FDA UDI | Class II | Unknown |
| Cannula 8mm SS, Non-Sterile | 8mm SS | FDA UDI | Class II | Active |
| CANNULA 16MM TEFLON STERILE - 1/packaging | CANNULA 16MM TEFLON STERILE | FDA UDI | Class II | Active |
| Cannula 2mm SS, Non-Sterile | 2mm SS | FDA UDI | Class II | Active |
| TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packaging | TRIPLE ARTERY CANNULA | FDA UDI | Class II | Active |
| Trident Cannula | Trident Cannula | FDA UDI | Class II | Active |
| CANNULA 14MM TEFLON STERILE - 1/packaging | CANNULA 14MM TEFLON STERILE | FDA UDI | Class II | Active |
| RM3 Tool Kit | RM3 Tool Kit | FDA UDI | Class II | Unknown |
| Dcm-100 Dual Kidney Cassette | DCM Kidney Cassette | FDA UDI | Class II | Active |
| Oxicom 2100 Oximeter | Oxicom 2100 | FDA UDI | Class II | Unknown |
| Cannula 5mm SS, Non-Sterile | 5mm SS | FDA UDI | Class II | Active |
| WCM Cassette (included in WCM cassettes kit) - 1/sterile bag | WCM Cassette | FDA UDI | Class II | Unknown |
| Cannula 13mm SS, Non-Sterile | 13mm SS | FDA UDI | Class II | Active |
| Arterial Perfusion Occlusion Clamp | Arterial Perfusion Occlusion Clamp | FDA UDI | Class II | Active |
| WAVES Specimen Tube | WAVES Specimen Tube | FDA UDI | Class II | Unknown |
| Cannula 10mm SS, Non-Sterile | 10mm SS | FDA UDI | Class II | Active |
| CUVETTES DC-80 Box 100 cuvettes | CUVETTE DC-80 | FDA UDI | Class II | Active |
| RM3 Accessory Filter | RM3 Accessory Filter | FDA UDI | Class II | Active |
| Control Liquid, Oxicom, Box | CONTROL LIQUID, OXICOM, BOX | FDA UDI | Class II | Active |
| Cannula 7mm SS, Non-Sterile | 7mm SS | FDA UDI | Class II | Active |
| CANNULA 8MM TEFLON STERILE - 1/packaging | CANNULA 8MM TEFLON STERILE | FDA UDI | Class II | Active |
| WAVES/WCM Sterile Drape | DRAPE STERILE PACK - 1drape/bag (included in WCM cassettes kit) | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 21, 2022 | Z-1013-2022 | — | terminated | There is a potential for the WCM cassette pump head leaking solution. |