Epic™ EMAX-1000

GUDID 05415067038470

Max Heart Valve Sizer Set For Use With Epic™ Max

ST. JUDE MEDICAL, INC.

Heart valve annulus sizer, reusable

• Primary Device ID: 05415067038470
• NIH Device Record Key: c355a843-96cf-4b4c-899e-2b82f032edd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic™
• Version Model Number: EMAX-1000
• Catalog Number: EMAX-1000
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	05415067038470 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

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

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

[05415067038470]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-07
• Device Publish Date: 2025-09-29

On-Brand Devices [Epic™]

• 05414734055666: Supra
• 05414734055659: Supra
• 05414734055642: Supra
• 05414734055635: Supra
• 05414734055628: Supra
• 05414734055611: Mitral
• 05414734055604: Mitral
• 05414734055598: Mitral
• 05414734055581: Aortic
• 05414734055574: Mitral
• 05414734055567: Aortic
• 05414734055550: Mitral
• 05414734055543: Aortic
• 05414734055536: Aortic
• 05414734055529: Aortic
• 05415067033154: Stented Tissue Valve
• 05415067033147: Stented Tissue Valve
• 05415067033130: Stented Tissue Valve
• 05415067033123: Stented Tissue Valve
• 05415067033116: Stented Tissue Valve
• 05415067033109: Stented Tissue Valve
• 05415067033093: Stented Tissue Valve
• 05415067033086: Stented Tissue Valve
• 05415067033079: Stented Tissue Valve
• 05415067033062: Stented Tissue Valve
• 05415067033055: Stented Tissue Valve
• 05415067033048: Stented Tissue Valve
• 05415067033031: Stented Tissue Valve
• 05415067033024: Stented Tissue Valve
• 05415067033017: Stented Tissue Valve
• 05415067034502: Heart Valve Sizer Set
• 05415067045478: Max Stented Tissue Valve
• 05415067045461: Max Stented Tissue Valve
• 05415067045454: Max Stented Tissue Valve
• 05415067045447: Max Stented Tissue Valve
• 05415067049070: Heart Valve Sizer Set
• 05415067038470: Max Heart Valve Sizer Set For Use With Epic™ Max