AccessGUDID - DEVICE: EDWARDS INTUITY ELITE VALVE SYSTEM (00690103194524)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS INTUITY ELITE VALVE SYSTEM
Version or Model: 8300KITB19
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8300KITB19A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103194524
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: EDWARDS INTUITY ELITE VALVE SYSTEM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
17453	Cardiac valvuloplasty catheter	A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device.	Active	false
60242	Aortic open-surgery heart valve bioprosthesis	A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWR	heart-valve, non-allograft tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P150036	000

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
Storage Environment Temperature: between 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: VALVE STENT DIAMETER, 19 MM

Device Record Status

Public Device Record Key: 37582cd5-8952-4f1a-96c2-2a6775fecc82
Public Version Date: May 22, 2025
Public Version Number: 5
DI Record Publish Date: September 02, 2016