FDA.reportPublic FDA data

SJM™ Masters Series HP Gelweave Valsalva

Primary DI
05414734009515
Brand
SJM™ Masters Series HP Gelweave Valsalva
Company
ST. JUDE MEDICAL, INC.
Model
27VAVGJ-515
Catalog number
27VAVGJ-515
Device description
St. Jude Medical Valved Graft HP 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
05414734009515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05414734009515054147340095155414734009515

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 Temperature0 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Store in cool, dry area.

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
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
05415067044334Regent™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