DEVICE: SJM™ Masters Series Hemashield™ (05414734027755)

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Device Identifier (DI) Information

SJM™ Masters Series Hemashield™
CAVGJ-514 00
31CAVGJ-514 00
ST. JUDE MEDICAL, INC.
05414734027755
GS1
1
St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
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Device Characteristics

MR Conditional
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft A sterile artificial substitute for a natural aortic heart valve fitted with a length of biologic-polymer blood vessel (vascular graft) intended to be implanted during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). The valve component consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about struts attached to the valve housing by hinges; the synthetic polymer blood vessel is designed to conform to the aortic root anatomy and is impregnated with a bioabsorbable animal-derived gelatin.
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FDA Product Code

[?]
Product Code Product Code Name
LWQ HEART-VALVE, MECHANICAL
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store in cool, dry area until needed.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 31 Millimeter
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Device Status

Not in Commercial Distribution
September 23, 2014
August 21, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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