Blood Circuit Set 114156

GUDID 30853072007030

The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.

Nuwellis Inc.

Haemofilter

• Primary Device ID: 30853072007030
• NIH Device Record Key: 8b641cdb-9b91-4fcf-8ebf-46d34aa65358
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Circuit Set
• Version Model Number: UF 500-HCT
• Catalog Number: 114156
• Company DUNS: 790580182
• Company Name: Nuwellis Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: false
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10853072007029 [Primary]
GS1	30853072007030 [Package]; Contains: 10853072007029; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• KDI: Dialyzer, High Permeability With Or Without Sealed Dialysate System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-11-25
• Device Publish Date: 2018-02-22

Devices Manufactured by Nuwellis Inc.

• 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: 2021-11-25The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy, and extended (longer than 8 hours) ultrafiltration treatment of patients with fluid overload who have failed diuretic therapy and require hospitalization.
• 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