FDA.reportPublic FDA data

SJM™ Masters Series

Primary DI
05414734006064
Brand
SJM™ Masters Series
Company
ST. JUDE MEDICAL, INC.
Model
MJ-501
Catalog number
21MJ-501
Published
2014-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
05414734006064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006064054147340060645414734006064

GMDN Terms#

Term, Definition table
TermDefinition
Mitral bi-leaflet mechanical heart valve prosthesisA sterile artificial substitute for a natural mitral 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 Diameter21Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store valve in a cool, dry area until needed.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
149818952
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05415067042934Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067042958Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067042972Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043016Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043030Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043054Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043139Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043153Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043177Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043252Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043276Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043290Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043313Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043337Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043450Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043610Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043658Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043672Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043719Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043733Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043757Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043795Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043818Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043832Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067043894Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044198Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044310Regent™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044938Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044976Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10
05415067044990Masters Series™ST. JUDE MEDICAL, INC.LWQ2025-01-10