AccessGUDID - DEVICE: Blood Circuit Set (07332414112370)

GUDID

Device Identifier (DI) Information

Brand Name: Blood Circuit Set
Version or Model: UF 500-HCT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 114157
Company Name: GAMBRO UF SOLUTIONS, INC

Primary DI Number: 07332414112370
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:	Yes
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?
44601	Haemofilter	A filter used in the process of haemofiltration, a treatment whereby extracorporeal blood is slowly and continuously passed through a system to allow for the removal of toxins and/or the replacement of electrolytes. The device functions with dialysate solution for the transfer of substances by diffusion and convection. This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 32 and 86 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1258b9f-380d-46e3-b0c0-9c09a0f3e93c
Public Version Date: July 20, 2023
Public Version Number: 3
DI Record Publish Date: September 29, 2015