FDA.report

SJM™ Masters Series

Primary DI
05414734006187
Brand
SJM™ Masters Series
Company
ST. JUDE MEDICAL, INC.
Model
MJ-501
Catalog number
23MJ-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

Related Records

Contact Domains

Product Codes

CodeName
LWQHEART-VALVE, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LWQHeart-Valve, MechanicalUnknown3

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05414734006187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05414734006187054147340061875414734006187

GMDN Terms

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

TypeValueUnit
Outer Diameter23Millimeter

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store valve in a 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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