CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT

Basic Information

• Brand Name: CARPENTIER-EDWARDS BIOPROSTHETIC VALVED CONDUIT
• Primary DI: 00690103021806
• Version / Model: 4300
• Catalog Number: 430016MM
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-09
• Public Version: 5
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 0d10567d-aca9-4b65-80c5-002f540bffe7

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DYE	replacement Heart-valve	Cardiovascular	870.3925	3

GMDN Terms

Code	Name	Definition	Implantable	Status
60350	Aortic 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103021806	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P870056	006
P870056	015
P870056	022
P870056	028
P870056	056

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			CONDUIT SIZE 16 MM, VALVE SIZE 17 MM

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 25 Degrees Celsius