Epic™

Basic Information

• Brand Name: Epic™
• Primary DI: 05415067033147
• Version / Model: ESP200-25
• Catalog Number: ESP200-25
• Company Name: ST. JUDE MEDICAL, INC.
• Labeler DUNS: 149818952
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-09
• Public Version: 2
• Public Version Date: 2022-01-20
• Public Version Status: Update
• Public Device Record Key: 7e31707e-6b47-478a-9c2b-5333c22ff99e

Device Description

Stented Tissue Valve

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
LWR	heart-valve, non-allograft tissue	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60242	Aortic heart valve bioprosthesis	A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05415067033147	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 41 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius