Blood Circuit Set 114157

GUDID 10853072007005

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.

CHF SOLUTIONS INC

Haemofilter

• Primary Device ID: 10853072007005
• NIH Device Record Key: 5ab81bc8-9681-4b1b-9c53-aaab029205bb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Blood Circuit Set
• Version Model Number: UF 500
• Catalog Number: 114157
• 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: 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
• 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 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 32 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
• Handling Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10853072007005 [Primary]
GS1	30853072007016 [Package]; 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: 2021-11-23
• Device Publish Date: 2018-02-22

Devices Manufactured by CHF SOLUTIONS INC

• 10853072007005 - Blood Circuit Set: 2021-11-23The 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.
• 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: 2020-03-11 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