AccessGUDID - DEVICE: Dual Lumen Extended Length Catheter and GALT insertion kit (07332414119324)

GUDID

Device Identifier (DI) Information

Brand Name: Dual Lumen Extended Length Catheter and GALT insertion kit
Version or Model: 115463
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 115463
Company Name: GAMBRO UF SOLUTIONS, INC

Primary DI Number: 07332414119324
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?	MR Unsafe
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?
46979	Double-lumen haemodialysis catheter, nonimplantable	A flexible, double-lumen tube intended to be used for short-term (< 30 days) central venous (jugular, subclavian vein) and/or femoral vein access, primarily during haemodialysis, to conduct blood from a patient and returning it after extracorporeal circulation; it may also be used during haemoperfusion and/or apheresis. It is intended for coaxial flow of blood and may be radiopaque; devices dedicated to catheter introduction/function (e.g., introducer needle) may be included. 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d86917ff-e1a0-497a-a1d2-db4d0ba2f75f
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: October 12, 2015