SJM™ Master Series 21METJ-504

GUDID 05414734055253

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 ID05414734055253
NIH Device Record Key79f1241f-c2f1-4702-8379-6ef3cfc47aa6
Commercial Distribution Discontinuation2020-04-07
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSJM™ Master Series
Version Model NumberMETJ-504
Catalog Number21METJ-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 Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 Millimeter
Outer Diameter21 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
GS105414734055253 [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 Date2014-11-10

Devices Manufactured by ST. JUDE MEDICAL, INC.

05415067047700 - TriClip™2024-04-22 G4 Delivery System
05415067047724 - TriClip™2024-04-22 G4 Delivery System
05415067047731 - TriClip™2024-04-22 G4 Delivery System
05415067047748 - TriClip™2024-04-22 Steerable Guide Catheter
05415067047755 - TriClip™2024-04-22 G4 Delivery System
05415067050014 - EnSite™2024-04-04 X EP System Software Upgrade
05415067050021 - EnSite™2024-04-04 X EP System TactiFlex Ablation Catheter, Sensor Enabled Software Upgrade
05415067050281 - EnSite™2024-04-04 X EP System PFA Catheter Visualization Temporary Software License
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.