Aquadex FlexFlow

Basic Information

• Brand Name: Aquadex FlexFlow
• Primary DI: 07332414112301
• Version / Model: 114158
• Catalog Number: 114158
• Company Name: GAMBRO UF SOLUTIONS, INC
• Labeler DUNS: 132629788
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-07
• Public Version: 3
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: f5228c4b-85a2-46bc-abfc-4cc9fd7c2797
• Distribution End Date: 2017-07-14

Device Description

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.

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	07332414112301	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -22 – 122 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity