Regent™ 25AGFN-756

GUDID 05415067044198

Mechanical Heart Valve

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 05415067044198
• NIH Device Record Key: 5abdfe52-4d96-4f10-bb24-9107d316cda0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Regent™
• Version Model Number: 25AGFN-756
• Catalog Number: 25AGFN-756
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter
• Outer Diameter: 25 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734006262 [Previous]
GS1	05415067044198 [Primary]

FDA Product Code

• LWQ: HEART-VALVE, MECHANICAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-20
• Device Publish Date: 2025-01-10

On-Brand Devices [Regent™]

• 05414734030991: Mechanical Heart Valve Sizer Set
• 05415067044310: Mechanical Heart Valve
• 05415067044198: Mechanical Heart Valve
• 05415067042958: Mechanical Heart Valve
• 05415067042934: Mechanical Heart Valve