Masters Series™ 21AJ-501

GUDID 05415067043016

Mechanical Heart Valve

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis

• Primary Device ID: 05415067043016
• NIH Device Record Key: deed5c0c-1095-4338-82c0-dfcb67144cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Masters Series™
• Version Model Number: 21AJ-501
• Catalog Number: 21AJ-501
• 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

Device Dimensions

• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter
• Outer Diameter: 21 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734021104 [Previous]
GS1	05415067043016 [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 [Masters Series™]

• 05415067042255: Replacement Holder/Rotators
• 05415067042231: Replacement Holder/Rotators
• 05415067044099: Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067044037: Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067043696: Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
• 05415067045393: Mechanical Heart Valve
• 05415067045379: Mechanical Heart Valve
• 05415067045355: Mechanical Heart Valve
• 05415067045294: Mechanical Heart Valve
• 05415067045270: Mechanical Heart Valve
• 05415067045256: Mechanical Heart Valve
• 05415067045232: Mechanical Heart Valve
• 05415067045218: Mechanical Heart Valve
• 05415067045195: Mechanical Heart Valve
• 05415067045171: Mechanical Heart Valve
• 05415067045157: Mechanical Heart Valve
• 05415067045119: Mechanical Heart Valve
• 05415067045072: Mechanical Heart Valve
• 05415067045058: Mechanical Heart Valve
• 05415067045034: Mechanical Heart Valve
• 05415067044990: Mechanical Heart Valve
• 05415067044976: Mechanical Heart Valve
• 05415067044938: HP Mechanical Heart Valve
• 05415067043894: HP Mechanical Heart Valve
• 05415067043832: HP Mechanical Heart Valve
• 05415067043818: HP Mechanical Heart Valve
• 05415067043795: Mechanical Heart Valve
• 05415067043757: Mechanical Heart Valve
• 05415067043733: Mechanical Heart Valve
• 05415067043719: HP Mechanical Heart Valve
• 05415067043672: HP Mechanical Heart Valve
• 05415067043658: HP Mechanical Heart Valve
• 05415067043610: HP Mechanical Heart Valve
• 05415067043450: Mechanical Heart Valve
• 05415067043337: Mechanical Heart Valve
• 05415067043313: Mechanical Heart Valve
• 05415067043290: Mechanical Heart Valve
• 05415067043276: HP Mechanical Heart Valve
• 05415067043252: Mechanical Heart Valve
• 05415067043177: Mechanical Heart Valve
• 05415067043153: Mechanical Heart Valve
• 05415067043139: Mechanical Heart Valve
• 05415067043054: Mechanical Heart Valve
• 05415067043030: Mechanical Heart Valve
• 05415067043016: Mechanical Heart Valve
• 05415067042972: HP Mechanical Heart Valve