FDA.reportPublic FDA data

SJM™ Masters SeriesHemashield™

Primary DI
05414734006422
Brand
SJM™ Masters SeriesHemashield™
Company
ST. JUDE MEDICAL, INC.
Model
27CAVGJ-514 00
Catalog number
27CAVGJ-514 00
Device description
St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
Published
2014-09-23
Public version status
Update
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
05414734006422PrimaryGS10
05415067044112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006422054147340064225414734006422
05415067044112054150670441125415067044112

GMDN Terms#

Term, Definition table
TermDefinition
Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graftA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter27Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius25 Degrees Celsius
Handling Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Keep dry.
Special Storage Condition, Specify00Store in cool, dry area until needed.
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

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
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