Home GUDID 3910140001 WAVES/WCM Sterile Drape
Primary DI 3910140001
Brand WAVES/WCM Sterile Drape
Company WATERS MEDICAL SYSTEMS, LLC
Model DRAPE STERILE PACK - 1drape/bag (included in WCM c
Catalog number 3910140.001
Device description Sterile WCM drape. For use with WAVES/WCM perfusion control unit.
Published 2017-02-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KDN System, Perfusion, Kidney
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDN System, Perfusion, Kidney Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 3910140001 Package HIBCC 6 In Commercial Distribution B154W39300050020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Kidney donor-organ preservation/transport perfusion set A collection of sterile devices intended to support and provide continuous physiologic organ perfusion to a donated kidney(s) during its preservation, evaluation, and transport in a kidney donor-organ preservation/transport system from the donor to the receiver hospital where the organ will be transplanted into the recipient. It typically includes a blood/fluid perfusion circuit, reservoir, pump, oxygenator, warmer, a urine collection reservoir, flow/pressure sensors, access and control valves, cannulae/connectors/tools to connect the appropriate vessels of the kidney and tubing lines, filters and bags to add/remove blood and solutions. This is a single-use device.
Regulatory Flags# DUNS number 556957871 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published B154W39300050020 WAVES/WCM Sterile Drape DRAPE STERILE PACK - 1drape/bag (included in WCM c 3910140.001 2017-02-12 B154W39300050123 WCM Kit WCM Kit 3930005.014 2017-02-12 B154R39000400040 RM3 RENAL PERFUSION MONITOR RM3 3900040.004 2017-01-23 B154W39201400226 WAVES Specimen Tube WAVES Specimen Tube 3930005.014 2017-02-12 B154W39300050110 WCM Cassette (included in WCM cassettes kit) - 1/sterile bag WCM Cassette 3930005.014 2017-02-12 B154O00067900000 Oxicom 3000 Oximeter Oxicom 3000 0006790.000 2017-02-12 B154O00072900000 Oxicom 2100 Oximeter Oxicom 2100 0007290.000 2017-02-12 B154OXIKIT21003 Oxicom 2100 Box Kit Oxicom 2100 Kit 0007290.000 2017-02-12 B154OXIKIT30003 Oxicom 3000 Box Kit Oxicom 3000 Kit 0006790.000 2017-02-12 B154R39100010043 RM3 Tool Kit RM3 Tool Kit 3910001.004 2017-03-27 B154W39000420000 WAVES CONTROL UNIT WAVES CONTROL UNIT 3900042.000 2017-02-12 B154W39300050150 WCM Training Cassette - Non Sterile WCM 3930005.015 2018-04-04 BI54W39301400070 WAVES Transport Bag WAVES Transport Bag 3930140.007 2017-02-12 B15431800030050 RM3 Filter RM3 Filter 3180003.005 2017-02-12 B154O00103910003 CUVETTES DC-80 Box 100 cuvettes & 100 plugs Cuvette/Plug Kit 0010391.000 2017-02-12 B154O0010391CUVEACH00 CUVETTES DC-80 Box 100 cuvettes CUVETTE DC-80 0010391.000 2017-02-12 B154O00340910000 CONTROL LIQUID, OXICOM, BOX CONTROL LIQUID, OXICOM, BOX 0034091.000 2017-02-12 B154O0034091HIG00 CONTROL LIQUID, OXICOM - High vial CONTROL LIQUID, OXICOM - High vial 0034091.000 2017-02-12 B154O0034091LOW00 CONTROL LIQUID, OXICOM - Low vial CONTROL LIQUID, OXICOM - Low vial 0034091.000 2017-02-12 B154O0034091MED00 CONTROL LIQUID, OXICOM - Medium vial CONTROL LIQUID, OXICOM - Medium vial 0034091.000 2017-02-12
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