Aquadex SmartFlow Console

Basic Information

• Brand Name: Aquadex SmartFlow Console
• Primary DI: 10853072007104
• Version / Model: 120100
• Catalog Number: 120100
• Company Name: Nuwellis Inc.
• Labeler DUNS: 790580182
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-03
• Public Version: 4
• Public Version Date: 2026-03-16
• Public Version Status: Update
• Public Device Record Key: 4f37d703-6e13-419a-a994-2cb15120a818

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35453	Haemofiltration system	An assembly of mains electricity (AC-powered) devices used to perform haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a filter to allow for the removal of toxins and fluids, and/or the replacement of electrolytes. It typically consists of an extracorporeal blood pump circuit, tubing, catheters, solution mixer, and an operator's console with a monitor. The system functions with dialysate solution and a haemofilter for the transfer of substances by diffusion and convection (ultrafiltration).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10853072007104	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K192756	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius