Epic™ E100-29A-00

GUDID 05414734055581

ST. JUDE MEDICAL, INC.

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID05414734055581
NIH Device Record Key755e28c0-2fd0-4eeb-ac66-a4cf08640ee4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEpic™
Version Model NumberAortic
Catalog NumberE100-29A-00
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734055581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

On-Brand Devices [Epic™]

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

Trademark Results [Epic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EPIC
EPIC
98388723 not registered Live/Pending
EPIC Disability Advocacy
2024-02-02
EPIC
EPIC
98358759 not registered Live/Pending
GEODynamics Inc.
2024-01-16
EPIC
EPIC
98358420 not registered Live/Pending
akram muhammad perviz
2024-01-16
EPIC
EPIC
98354891 not registered Live/Pending
Stellar Day Services, LLC
2024-01-12
EPIC
EPIC
98290719 not registered Live/Pending
EPIC WEB3, INC.
2023-11-29
EPIC
EPIC
98163606 not registered Live/Pending
Pona Consulting, L.3.C.
2023-09-04
EPIC
EPIC
98086392 not registered Live/Pending
Liquid Core Gum Company, LLC
2023-07-14
EPIC
EPIC
98059107 not registered Live/Pending
Young People In Recovery
2023-06-26
EPIC
EPIC
98035144 not registered Live/Pending
New Image Labs Corporation
2023-06-09
EPIC
EPIC
98034879 not registered Live/Pending
United WELD Holdings, LP
2023-06-09
EPIC
EPIC
98034876 not registered Live/Pending
United WELD Holdings, LP
2023-06-09
EPIC
EPIC
98022564 not registered Live/Pending
Le, Chris
2023-06-01

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