SJM™ Masters Series 23METJ-504

GUDID 05414734055277

Mitral Expanded PTFE Rotatable Mechanical Heart Valve

ST. JUDE MEDICAL, INC.

Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis Mitral bi-leaflet mechanical heart valve prosthesis
Primary Device ID05414734055277
NIH Device Record Keycf42ca63-94f3-486e-94ed-bcc335d2ff5d
Commercial Distribution Discontinuation2020-04-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSJM™ Masters Series
Version Model NumberMETJ-504
Catalog Number23METJ-504
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Device Dimensions

Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter
Outer Diameter23 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store valve in a cool, dry area until needed.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734055277 [Primary]

FDA Product Code

LWQHEART-VALVE, MECHANICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-05-06
Device Publish Date2014-09-23

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