MITROFLOW VALSALVA CONDUIT

Basic Information

• Brand Name: MITROFLOW VALSALVA CONDUIT
• Primary DI: 08022057014948
• Version / Model: MVC
• Company Name: Corcym Canada Corp
• Labeler DUNS: 204322622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-22
• Public Version: 6
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 8edbf984-9275-4499-8167-d6c4c73e237f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
LWR	heart-valve, non-allograft tissue	Unknown		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	08022057014948	GS1

Premarket Submissions

Submission Number	Supplement Number
P060038	012