FDA.report

SJM™ Masters Series Hemashield™

Primary DI
05414734006019
Brand
SJM™ Masters Series Hemashield™
Company
ST. JUDE MEDICAL, INC.
Model
CAVGJ-514 00
Catalog number
21CAVGJ-514 00
Device description
St. Jude Medical Valved Graft Rotatable Mechanical Heart Valve
Published
2014-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LWQHEART-VALVE, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LWQHeart-Valve, MechanicalUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734006019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734006019054147340060195414734006019

GMDN Terms

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

TypeValueUnit
Outer Diameter21Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry area until needed.

Sterilization Methods

Method

Contacts

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

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