Address:2112 15TH ST NW,ROCHESTER,MN,55901,US
Device Description : Arterial Perfusion Occlusion Clamp - 2ct/pkg
Device Class :
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : The WAVES “single kidney” machine perfusion device is a three-part system compos 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.
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : Tubes for specimen collection.
Device Class :
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : The cassette is a self-contained circulation system consisting of an organ chamb 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.
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. 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
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : WCM Training Cassette - Non Sterile
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No
Device Description : Transport bag specifically designed to accommodate a running WAVES unit to allow Transport bag specifically designed to accommodate a running WAVES unit to allow easier handling for transplant activities.
Device Class : 2
Duns Number: 556957871
Premarket Exempt : No
Prescription Use : No