AccessGUDID - DEVICE: Aquadex FlexFlow (07332414112301)

GUDID

Device Identifier (DI) Information

Brand Name: Aquadex FlexFlow
Version or Model: 114158
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 114158
Company Name: GAMBRO UF SOLUTIONS, INC

Primary DI Number: 07332414112301
Issuing Agency: GS1
Commercial Distribution End Date: July 14, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 132629788 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDI	Dialyzer, high permeability with or without sealed dialysate system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 700 and 1060 KiloPascal
Handling Environment Temperature: between -22 and 122 Degrees Fahrenheit
Handling Environment Temperature: between -30 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f5228c4b-85a2-46bc-abfc-4cc9fd7c2797
Public Version Date: July 20, 2023
Public Version Number: 3
DI Record Publish Date: October 07, 2015