Dual Lumen Extended Length Catheter (11cm) 320101

GUDID 10853072007159

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.

Nuwellis Inc.

Double-lumen haemodialysis catheter, nonimplantable
Primary Device ID10853072007159
NIH Device Record Key504cbb7d-6d49-4fbb-9b83-c024cc36f0ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameDual Lumen Extended Length Catheter (11cm)
Version Model Number320101
Catalog Number320101
Company DUNS790580182
Company NameNuwellis Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com
Phone1-855-786-2778
Emailsupport@nuwellis.com

Device Dimensions

Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter
Catheter Working Length11 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110853072007159 [Primary]
GS130853072007160 [Package]
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQJCatheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-28
Device Publish Date2024-02-20

Devices Manufactured by Nuwellis Inc.

10853072007159 - Dual Lumen Extended Length Catheter (11cm)2024-02-28The 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.
10853072007159 - Dual Lumen Extended Length Catheter (11cm)2024-02-28 The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically f
30853072007184 - Dual Lumen Extended Length Catheter (15cm)2024-02-28 The dELC is a 6 F reverse taper dual lumen venous access device with stainless steel coil reinforcement, designed specifically f
30853072007221 - Dual Lumen Extended Length Catheter (11cm) and GALT Insertion Kit2024-02-28 This Kit includes a dELC Catheter (11cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access dev
30853072007245 - Dual Lumen Extended Length Catheter (15cm) and GALT Insertion Kit2024-02-28 This Kit includes a dELC Catheter (15cm) and a GALT Insertion Kit. The dELC is a 6 F reverse taper dual lumen venous access dev
30853072007306 - AquaFlexFlow UF 500 Plus - 24 Hr2021-12-01 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8
30853072007030 - Blood Circuit Set2021-11-25 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
10853072007074 - Aquadex FlexFlow2021-11-25 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have

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