DEVICE: SJM™ Masters Series (05414734053884)
Device Identifier (DI) Information
SJM™ Masters Series
AECJ-502
In Commercial Distribution
21AECJ-502
ST. JUDE MEDICAL, INC.
AECJ-502
In Commercial Distribution
21AECJ-502
ST. JUDE MEDICAL, INC.
No description.
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 | A sterile artificial substitute for a natural aortic heart valve intended to be implanted during open heart surgery typically to treat acquired or congenital valvular disease. It consists of two flat, semicircular, pyrolytic carbon-coated or polymer leaflets that pivot about pyrolytic carbon or metal struts attached to the valve housing by hinges; the hinge points intersect the valve lumen resulting in a total of three openings. When pressurized blood hits the valve, the two halves of the circle fold away from the valve ring and allow blood to flow into the three openings before the valve flaps close again. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LWQ | HEART-VALVE, MECHANICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store valve in cool, dry area until needed |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 21 Millimeter |
Device Record Status
b31c50ec-f7f0-4d72-808c-643d837ccdc7
March 29, 2018
2
September 23, 2014
March 29, 2018
2
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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com