Waters Medical Systems L L C

FDA Filings

This page includes the latest FDA filings for Waters Medical Systems L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2123774
FEI Number2123774
NameWATERS MEDICAL SYSTEMS, LLC
Owner & OperatorWaters Medical Systems LLC
Contact Address2112 15th Street NW
Rochester MN 55901 US
Official Correspondent
  • Samuel T Wiegand
  • x-507-2523705-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2112 15TH ST NW
ROCHESTER, MN 55901 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
WATERS MEDICAL SYSTEMS, LLC
WAVES Transport Bag 3930140.0072019-03-21
WATERS MEDICAL SYSTEMS, LLC
WCM Training Cassette - Non Sterile 3930005.0152019-03-21
WATERS MEDICAL SYSTEMS, LLC
WCM Cassette (included in WCM cassettes kit) - 1/s 3930005.0142019-03-21
WATERS MEDICAL SYSTEMS, LLC
Arterial Perfusion Occlusion Clamp 3920140.0242019-03-21
WATERS MEDICAL SYSTEMS, LLC
Trident Cannula 3920140.0232019-03-21
WATERS MEDICAL SYSTEMS, LLC
Cannula 14mm SS, Non-Sterile 3910142.0142019-03-21
WATERS MEDICAL SYSTEMS, LLC
Cannula 13mm SS, Non-Sterile 3910142.0132019-03-21
WATERS MEDICAL SYSTEMS, LLC
Cannula 12mm SS, Non-Sterile 3910142.0122019-03-21
WATERS MEDICAL SYSTEMS, LLC
Cannula 11mm SS, Non-Sterile 3910142.0112019-03-21
WATERS MEDICAL SYSTEMS, LLC
Cannula 7mm SS, Non-Sterile 3910142.0072019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 15MM TEFLON STERILE - 1/packaging 3910141.0152019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 12MM TEFLON STERILE - 1/packaging 3910141.0122019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 11MM TEFLON STERILE - 1/packaging 3910141.0112019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 9MM TEFLON STERILE - 1/packaging 3910141.0092019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 7MM TEFLON STERILE - 1/packaging 3910141.0072019-03-21
WATERS MEDICAL SYSTEMS, LLC
CANNULA 3MM TEFLON STERILE - 1/packaging 3910141.0032019-03-21
WATERS MEDICAL SYSTEMS, LLC
RM3 Tool Kit 3910001.0042019-03-21
WATERS MEDICAL SYSTEMS, LLC
RM3 Accessory - Filter/Adapter 3900056.0012019-03-21
WATERS MEDICAL SYSTEMS, LLC
RM3 RENAL PERFUSION MONITOR 3900040.0042019-03-21
WATERS MEDICAL SYSTEMS, LLC
TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packagin 0015093.0012019-03-21
WATERS MEDICAL SYSTEMS, LLC
DCM100 Training Cassette - Non Sterile 0012691.0052019-03-21
WATERS MEDICAL SYSTEMS, LLC
MOX/RM3 Battery 0006004.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
Oxicom 3000 Box Kit 0006790.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
Oxicom 2100 Box Kit 0007290.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CUVETTES DC-80 Box 100 cuvettes - Plugs 0010391.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CONTROL LIQUID, OXICOM - Medium vial 0034091.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CONTROL LIQUID, OXICOM - Low vial 0034091.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CONTROL LIQUID, OXICOM - High vial 0034091.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CONTROL LIQUID, OXICOM, BOX 0034091.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CUVETTES DC-80 Box 100 cuvettes 0010391.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
CUVETTES DC-80 Box 100 cuvettes & 100 plugs 0010391.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
Oxicom 2100 Oximeter 0007290.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
Oxicom 3000 Oximeter 0006790.0002019-03-21
WATERS MEDICAL SYSTEMS, LLC
RM3 Filter 3180003.0052019-03-21
WATERS MEDICAL SYSTEMS, LLC
WCM Kit 3930005.0142019-03-21
WATERS MEDICAL SYSTEMS, LLC
WAVES/WCM Sterile Drape 3910140.0012019-03-21
WATERS MEDICAL SYSTEMS, LLC
WAVES Specimen Tube 3930005.0142019-03-20
WATERS MEDICAL SYSTEMS, LLC
WAVES CONTROL UNIT 3900042.0002019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 10mm SS, Non-Sterile 3910142.0102019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 9mm SS, Non-Sterile 3910142.0092019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 8mm SS, Non-Sterile 3910142.0082019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 6mm SS, Non-Sterile 3910142.0062019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 5mm SS, Non-Sterile 3910142.0052019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 4mm SS, Non-Sterile 3910142.0042019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 3mm SS, Non-Sterile 3910142.0032019-03-20
WATERS MEDICAL SYSTEMS, LLC
Cannula 2mm SS, Non-Sterile 3910142.0022019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 16MM TEFLON STERILE - 1/packaging 3910141.0162019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 14MM TEFLON STERILE - 1/packaging 3910141.0142019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 13MM TEFLON STERILE - 1/packaging 3910141.0132019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 10MM TEFLON STERILE - 1/packaging 3910141.0102019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 8MM TEFLON STERILE - 1/packaging 3910141.0082019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 6MM TEFLON STERILE - 1/packaging 3910141.0062019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 5MM TEFLON STERILE - 1/packaging 3910141.0052019-03-20
WATERS MEDICAL SYSTEMS, LLC
CANNULA 4MM TEFLON STERILE - 1/packaging 3910141.0042019-03-20
WATERS MEDICAL SYSTEMS, LLC
RM3 Accessory - Adapter 3200091.0052019-03-20
WATERS MEDICAL SYSTEMS, LLC
RM3 Accessory Filter 3900056.0012019-03-20
WATERS MEDICAL SYSTEMS, LLC
DCM-100 DUAL KIDNEY CASSETTE 0012691.0002019-03-20
WATERS MEDICAL SYSTEMS, LLC
INSULATED CASSETTE COVER DCM 0008129.0002019-03-20
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Perf-Gen2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Bel-Gen2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Bel-Gen2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
PPS2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
CoStorSol2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
CSS2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Oxicom Liquid Control2016-06-06
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS2014-12-04
WATERS MEDICAL SYSTEMS, LLC
PERF-GEN PULSATILE PERFUSION SOLUTION2013-08-16
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Oxicom 30002013-08-13
WATERS MEDICAL SYSTEMS, LLC
BEL-GEN COLD STORAGE SOLUTION2013-06-14
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
WAVES2012-12-12
WATERS MEDICAL SYSTEMS, LLC
WAVES2012-02-16
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
RM3 Renal Preservation Machine2008-07-31
WATERS MEDICAL SYSTEMS, LLC [Waters Medical Systems LLC]
Oxicom 21002008-07-31

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