AccessGUDID - DEVICE: Epic™ (05414734055598)

GUDID

Device Identifier (DI) Information

Brand Name: Epic™
Version or Model: E100-29M-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E100-29M-00
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734055598
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 149818952 *Terms of Use

Device Description: St. Jude Medical Porcine Mitral Bioprosthetic Heart Valve

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60244	Mitral 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 mitral 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWR	heart-valve, non-allograft tissue

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 29 Millimeter

Device Record Status

Public Device Record Key: f0f0004d-6d59-4776-9b9b-0806f5f5ef55
Public Version Date: September 27, 2021
Public Version Number: 6
DI Record Publish Date: September 23, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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