Epic™ E100-33M-00

GUDID 05414734055611

ST. JUDE MEDICAL, INC.

Mitral heart valve bioprosthesis

• Primary Device ID: 05414734055611
• NIH Device Record Key: b4118bed-8717-449d-8973-8348e952c1ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Epic™
• Version Model Number: Mitral
• Catalog Number: E100-33M-00
• 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: true
• 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
• 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: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter
• Outer Diameter: 33 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Store the valve in the upright position. If temperature indicator is Red, do not use.
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734055611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P040021

FDA Product Code

• LWR: heart-valve, non-allograft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

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