Aquadex SmartFlow Console 120100

GUDID 10853072007104

The Aquadex SmartFlow 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.

CHF SOLUTIONS INC

Haemofiltration system

• Primary Device ID: 10853072007104
• NIH Device Record Key: 4f37d703-6e13-419a-a994-2cb15120a818
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquadex SmartFlow Console
• Version Model Number: 120100
• Catalog Number: 120100
• Company DUNS: 790580182
• Company Name: CHF SOLUTIONS 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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@chf-solutions.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
• 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 -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -30 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10853072007104 [Primary]

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: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-11
• Device Publish Date: 2020-03-03

Devices Manufactured by CHF SOLUTIONS INC

• 10853072007005 - Blood Circuit Set: 2021-11-23 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 50853072007065 - Dual Lumen Extended Length Catheter: 2021-02-05 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 30853072007092 - Dual Lumen Extended Length Catheter and GALT insertion kit: 2021-02-05 The Aquadex System is indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload who have
• 10853072007104 - Aquadex SmartFlow Console: 2020-03-11The Aquadex SmartFlow 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.
• 10853072007104 - Aquadex SmartFlow Console: 2020-03-11 The Aquadex SmartFlow System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (lon
• 10853072007111 - AquaFlexFlow UF 500 Plus: 2020-03-11 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8
• 10853072007128 - AquaFlexFlow UF 500: 2020-03-11 For use with the Aquadex System. The Aquadex System is indicated for: Continuous ultrafiltration therapy for temporary (up to 8