AccessGUDID - DEVICE: CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT (00690103021851)

GUDID

Device Identifier (DI) Information

Brand Name: CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT
Version or Model: 4300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 430030MM
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103021851
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: No description.

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):	No
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?
60350	Aortic open-surgery heart valve bioprosthesis/synthetic polymer aorta graft	An implantable xenograft (e.g., porcine or bovine heart valve) fitted with a length of synthetic polymer blood vessel (vascular graft) intended to be implanted in the heart during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). It is processed to render the tissue in the valve non-viable while the attached synthetic blood vessel is designed to conform to the aortic root anatomy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DYE	replacement Heart-valve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P870056	006
P870056	015
P870056	022
P870056	028
P870056	056

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: CONDUIT SIZE 30 MM, VALVE SIZE 31 MM

Device Record Status

Public Device Record Key: 1ecd14c2-3b86-41cc-a7b1-a683cc4072c1
Public Version Date: May 22, 2025
Public Version Number: 6
DI Record Publish Date: September 09, 2015