FDA.reportPublic FDA data

Regent™

Primary DI
05415067044334
Brand
Regent™
Company
ST. JUDE MEDICAL, INC.
Model
25AGN-751
Catalog number
25AGN-751
Device description
Mechanical Heart Valve
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWQHEART-VALVE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWQHeart-Valve, MechanicalUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05414734006279PreviousGS10
05415067044334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006279054147340062795414734006279
05415067044334054150670443345415067044334

GMDN Terms#

Term, Definition table
TermDefinition
Aortic bi-leaflet mechanical heart valve prosthesisAn 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter25Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734400596MTS™118311832015-04-25
05414734403382NA724172412015-03-24
05414734405157SJM™162716272015-03-12
05415067016560SJM™303230322015-07-29
05415067018533SJM™121312132015-07-29
05415067018854SJM™121412142015-07-29
05415067027863NA703270322017-11-16
05415067052933Current™A-UNI-PF-CBLA-UNI-PF-CBL2026-04-20
05415067053893Current™PFA-GEN-V102PFA-GEN-V1022026-04-20
05415067056108EnSite™ENSITE-RL-MPENSITE-RL-MP2026-04-17
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05414734400749Tennafix™120512052015-09-08
05414734405355SJM™301330132015-04-25
05415067016119NA231123112015-03-12
05415067016126SJM™23162316ANS2015-03-12
05415067016133SJM™23212321ANS2015-04-22
05415067016140NA232623262015-04-22
05415067016683NA231623162015-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067042996Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043078Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043092Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043115Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043191Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043214Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043238Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043351Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043399Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043412Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043436Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043474Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043498Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043511Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043535Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043559Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043573Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043597Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043634Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043771Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043856Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043870Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044174Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044211Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044273Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044297Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044358Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044952Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067045010Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067045096Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10