Masters Series™

Basic Information

• Brand Name: Masters Series™
• Primary DI: 05415067044150
• Version / Model: 31CAVGJ-514 00
• Catalog Number: 31CAVGJ-514 00
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-12-18
• Public Version: 1
• Public Version Date: 2024-12-26
• Public Version Status: New
• Public Device Record Key: 606c2028-6a48-4ace-bab7-6f00993460f0

Device Description

Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft

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
LWQ	HEART-VALVE, MECHANICAL	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60423	Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft	An artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted 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). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	05414734006583	GS1
Primary	05415067044150	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	31.0000	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry,