wtrs.comPERF-GEN PULSATILE PERFUSION SOLUTION
WATERS MEDICAL SYSTEMS, LLC
WATERS MEDICAL SYSTEMS, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 2123774 | 2123774 | WATERS MEDICAL SYSTEMS, LLC | 1 | Y | 2026-01-01 | 2900 37th St NW Building 003 ROCHESTER MN US 55901 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| B154O00067900000 | Oxicom 3000 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2). | 507-288-7777 | info@wtrs.com |
| B154O00072900000 | Oxicom 2100 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood. | 507-288-7777 | info@wtrs.com |
| B154OXIKIT21003 | Oxicom 2100 Box Kit - Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks | 507-288-7777 | info@wtrs.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 83046 | 1398193225 | K991594 | CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTS | MSB | 1999-08-05 |
| 83046 | 1845457735 | K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | KDN | 1997-07-29 |
| 83046 | 1557590702 | K921519 | OXICOM-2100 | DQA | 1992-10-23 |
| 83046 | 1414761650 | K911207 | OXICOMPLUS | DQA | 1991-08-26 |
| 83046 | 1738214862 | K221387 | BEL-GEN Cold Storage Solution | KDL | 2022-06-14 |
| 83046 | 1721901989 | K221386 | PERF-GEN Pulsatile Perfusion Solution | KDL | 2022-06-14 |
| 83046 | 1401967044 | K211224 | RM4 Control Unit | KDN | 2021-10-15 |
| 83046 | 2073597761 | K121736 | PERF-GEN PULSATILE PERFUSION SOLUTION | KDL | 2013-08-16 |
| 83046 | 2073682351 | K121618 | BEL-GEN COLD STORAGE SOLUTION | KDL | 2013-06-14 |
| 83046 | 1636720864 | K111521 | WAVES | KDN | 2012-02-16 |
| 83046 | 1238833918 | K080432 | MAPERSOL | KDN | 2008-08-08 |
| 83046 | 1231328734 | K073693 | COSTORSOL | KDN | 2008-07-03 |
| 83046 | 1173347417 | K053327 | OXICOM CONTROL | JJX | 2006-01-26 |
Product Codes Associated With Registrations#
PMN#
BEL-GEN COLD STORAGE SOLUTION
WATERS MEDICAL SYSTEMS, LLC
WAVES
WATERS MEDICAL SYSTEMS, LLC
GUDID#
WAVES/WCM Sterile Drape - Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
2017-02-12
WCM Kit - DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes
2017-02-12
RM3 RENAL PERFUSION MONITOR - RM3
2017-01-23
WAVES Specimen Tube - Tubes for specimen collection.
2017-02-12
WCM Cassette (included in WCM cassettes kit) - 1/sterile bag - The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc.
2017-02-12
Oxicom 3000 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2).
2017-02-12
Oxicom 2100 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood.
2017-02-12
Oxicom 2100 Box Kit - Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks
2017-02-12
Oxicom 3000 Box Kit - Oxicom 3000 Box Kit containing 100ct cuvette/plugs & QC 1,2,3 sticks
2017-02-12
RM3 Tool Kit
2017-03-27
WAVES CONTROL UNIT - The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation.
2017-02-12
WCM Training Cassette - Non Sterile - WCM
2018-04-04
WAVES Transport Bag - Transport bag specifically designed to accommodate a running WAVES unit to allow easier handling for transplant activities.
2017-02-12
RM3 Filter - RM3 Accessory - Filter
2017-02-12
CUVETTES DC-80 Box 100 cuvettes & 100 plugs - Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.
2017-02-12
CUVETTES DC-80 Box 100 cuvettes - Disposable cuvettes for use with the Oxicom oximeter.
2017-02-12
CONTROL LIQUID, OXICOM, BOX - Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range. Box contains 3 vials of high range, 3 vials of medium range and 3 vials of low range.
2017-02-12
CONTROL LIQUID, OXICOM - High vial - Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range.
2017-02-12
CONTROL LIQUID, OXICOM - Low vial - Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range.
2017-02-12
CONTROL LIQUID, OXICOM - Medium vial - Weekly use of liquid controls are important for calibration verification of the Oxicom. Liquid controls are available in three levels – for monitoring performance of significant points within the clinical range.
2017-02-12
CUVETTES DC-80 Box 100 cuvettes - Plugs - Disposable cuvettes for use with the Oxicom 2100 and 3000 oximeter.
2017-02-12
MOX/RM3 Battery - Replacement battery for use in the MOX/RM3 control unit.
2017-02-12
DCM100 Training Cassette - Non Sterile - DCM100
2018-04-04
TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packaging - TRIPLE ARTERY CANNULA
2017-02-12
RM3 Accessory - Filter/Adapter - Filter/Adapter for RM3 Control Unit. Contains DIs: 25ct of both 3180003005 and 32000910005
2017-02-12
CANNULA 3MM TEFLON STERILE - 1/packaging - CANNULA 3MM TEFLON STERILE
2017-02-12
CANNULA 7MM TEFLON STERILE - 1/packaging - CANNULA 7MM TEFLON STERILE
2017-02-12
CANNULA 9MM TEFLON STERILE - 1/packaging - CANNULA 9MM TEFLON STERILE
2017-02-12
CANNULA 11MM TEFLON STERILE - 1/packaging - CANNULA 11MM TEFLON STERILE
2017-02-12
CANNULA 12MM TEFLON STERILE - 1/packaging - CANNULA 12MM TEFLON STERILE
2017-02-12
CANNULA 15MM TEFLON STERILE - 1/packaging - CANNULA 15MM TEFLON STERILE
2017-02-12
Cannula 7mm SS, Non-Sterile - Cannula 7mm Stainless Steel, Non-Sterile
2018-05-02
Cannula 11mm SS, Non-Sterile - Cannula 11mm Stainless Steel, Non-Sterile
2018-05-02
Cannula 12mm SS, Non-Sterile - Cannula 12mm Stainless Steel, Non-Sterile
2018-05-02
Cannula 13mm SS, Non-Sterile - Cannula 13mm Stainless Steel, Non-Sterile
2018-05-02
Cannula 14mm SS, Non-Sterile - Cannula 14mm Stainless Steel, Non-Sterile
2018-05-02
Trident Cannula - RM3 Accessory Trident Cannula
2017-02-12
Arterial Perfusion Occlusion Clamp - Arterial Perfusion Occlusion Clamp - 2ct/pkg
2017-02-12
WAVES/WCM Sterile Drape - Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
2017-02-12
WCM Kit - DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (
2017-02-12