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 ID: 10853072007159
• NIH Device Record Key: 504cbb7d-6d49-4fbb-9b83-c024cc36f0ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Lumen Extended Length Catheter (11cm)
• Version Model Number: 320101
• Catalog Number: 320101
• Company DUNS: 790580182
• Company Name: Nuwellis Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com
• Phone: 1-855-786-2778
• Email: support@nuwellis.com

Device Dimensions

• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter
• Catheter Working Length: 11 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10853072007159 [Primary]
GS1	30853072007160 [Package]; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233515

FDA Product Code

• NQJ: Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-28
• Device Publish Date: 2024-02-20

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 Kit: 2024-02-28 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 Kit: 2024-02-28 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 Hr: 2021-12-01 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8
• 30853072007030 - Blood Circuit Set: 2021-11-25 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 10853072007074 - Aquadex FlexFlow: 2021-11-25 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have