AccessGUDID - DEVICE: Edwards EVOQUE Valve (00690103219074)

GUDID

Device Identifier (DI) Information

Brand Name: Edwards EVOQUE Valve
Version or Model: 9850EV56US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9850EV56US
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103219074
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: Edwards EVOQUE Valve, 56mm

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:	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?
65121	Tricuspid transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine) intended to be used to repair/replace a stenosed or regurgitant tricuspid heart valve, or previously-implanted tricuspid heart valve prosthesis, and which is implanted using a catheter via percutaneous access (e.g., transfemoral, transapical) while the heart is beating. It is comprised of the xenograft, processed to render the tissue non-viable, attached to a metal framework (which may be covered with a synthetic polymer material) that is expandable in situ; it may also include a synthetic polymer subannular valve anchoring component. Devices to assist implantation (e.g., catheter, introducer) are typically included with the device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPW	Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P230013	000
P230013	004

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 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a66bc8fc-df0c-4dab-8101-9a61582901b3
Public Version Date: July 10, 2025
Public Version Number: 2
DI Record Publish Date: October 03, 2024