Home GUDID 10853072007159 Dual Lumen Extended Length Catheter (11cm)
Primary DI 10853072007159
Brand Dual Lumen Extended Length Catheter (11cm)
Company Nuwellis Inc.
Model 320101
Catalog number 320101
Device description The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically for use with the Aquadex systems. The catheter is inserted into the peripheral venous circulation by way of a peel away introducer.
Published 2024-02-20
Public version status Update
Distribution status In Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name MPB Catheter, Hemodialysis, Non-Implanted NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MPB Catheter, Hemodialysis, Non-Implanted Gastroenterology, Urology 2 NQJ Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30853072007160 Package GS1 5 In Commercial Distribution 10853072007159 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30853072007160 30853072007160 10853072007159 10853072007159
GMDN Terms# Term, Definition table Term Definition Double-lumen haemodialysis catheter, nonimplantable A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Catheter Working Length 11 Centimeter
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 Lot or batch true Expiration date on label true No natural rubber latex true 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 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 30853072007306 AquaFlexFlow UF 500 Plus - 24 Hr 210104 210104 2021-11-23 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
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