Home GUDID 30853072007306 AquaFlexFlow UF 500 Plus - 24 Hr
Primary DI 30853072007306
Brand AquaFlexFlow UF 500 Plus - 24 Hr
Company Nuwellis Inc.
Model 210104
Catalog number 210104
Device description For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered within an outpatient or inpatient clinical setting by a healthcare provider, under physician prescription, both of whom having received training in extracorporeal therapies.
Published 2021-11-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30853072007306 Package GS1 5 In Commercial Distribution 10853072007289 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30853072007306 30853072007306 10853072007289 10853072007289
GMDN Terms# Term, Definition table Term Definition Haemofilter A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 20 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 790580182 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 true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10853072007173 Dual Lumen Extended Length Catheter (15cm) 320102 320102 2024-02-20 10853072007210 Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit 320111 320111 2024-02-20 10853072007289 AquaFlexFlow UF 500 Plus - 24 Hr 210104 210104 2021-11-23 10853072007159 Dual Lumen Extended Length Catheter (11cm) 320101 320101 2024-02-20 10853072007104 Aquadex SmartFlow Console 120100 120100 2020-03-03 10853072007111 AquaFlexFlow UF 500 Plus 114156 114156 2020-03-03 10853072007128 AquaFlexFlow UF 500 114157 114157 2020-03-03 10853072007234 Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit 320112 320112 2024-02-20 30853072007184 Dual Lumen Extended Length Catheter (15cm) 320102 320102 2024-02-20 30853072007221 Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit 320111 320111 2024-02-20 30853072007245 Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit 320112 320112 2024-02-20 10853072007029 Blood Circuit Set UF 500-HCT 114156 2018-02-22 10853072007043 Dual Lumen Extended Length Catheter 114153 114153 2018-08-16 10853072007081 Dual Lumen Extended Length Catheter and GALT insertion kit 115463 115463 2018-05-24 30853072007030 Blood Circuit Set UF 500-HCT 114156 2018-02-22 10853072007074 Aquadex FlexFlow 114158 114158 2018-01-11 10853072007005 Blood Circuit Set UF 500 114157 2018-02-22
Other Devices Sharing Product Codes# 
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