AquaFlexFlow UF 500 Plus - 24 Hr 210104

GUDID 30853072007306

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.

Nuwellis Inc.

Haemofilter

• Primary Device ID: 30853072007306
• NIH Device Record Key: d9e28b54-5e90-47dc-a5d3-a9f3e6228b19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AquaFlexFlow UF 500 Plus - 24 Hr
• Version Model Number: 210104
• Catalog Number: 210104
• 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: true
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10853072007289 [Primary]
GS1	30853072007306 [Package]; Contains: 10853072007289; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192756

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-01
• Device Publish Date: 2021-11-23

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: 2021-12-01For 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.
• 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