DEVICE: SJM™ Masters Series HP (05414734006293)
Device Identifier (DI) Information
SJM™ Masters Series HP
25AHPJ-505
In Commercial Distribution
25AHPJ-505
ST. JUDE MEDICAL, INC.
25AHPJ-505
In Commercial Distribution
25AHPJ-505
ST. JUDE MEDICAL, INC.
Aortic HP Rotatable Mechanical Heart Valve
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60240 | Aortic bi-leaflet mechanical heart valve prosthesis |
An 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.
|
Active | true |
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: 25 Millimeter |
Device Record Status
5a8dfc88-0b84-47dd-9345-00b06d72033c
February 05, 2021
4
November 04, 2014
February 05, 2021
4
November 04, 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