FDA.reportPublic FDA data

SJM™ Masters Series Hemashield™

Primary DI
05414734006514
Brand
SJM™ Masters Series Hemashield™
Company
ST. JUDE MEDICAL, INC.
Model
CAVGJ-514 00
Catalog number
29CAVGJ-514 00
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
05414734006514PrimaryGS10
05415067044136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734006514054147340065145414734006514
05415067044136054150670441365415067044136

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 Diameter29Millimeter

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
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