SJM Regent™ 25AGN-751

GUDID 05414734006279

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis Aortic bi-leaflet mechanical heart valve prosthesis
Primary Device ID05414734006279
NIH Device Record Keyca84856f-a045-4c23-a6bf-6f73b1732ec0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM Regent™
Version Model NumberAGN-751
Catalog Number25AGN-751
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 Datetrue
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 Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter
Outer Diameter25 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.
Special Storage Condition, SpecifyBetween 0 and 0 *Store SJM Regent Mechanical Heart Valve in cool, dry area until needed.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734006279 [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 Number2
Public Version Date2018-03-29
Device Publish Date2014-09-23

On-Brand Devices [SJM Regent™ ]

05414734009256Mechanical Heart Valve
05414734006392AGN-751
05414734006385AGFN-756
05414734006279AGN-751
05414734006262AGFN-756
05414734006101AGN-751
05414734006095AGFN-756
05414734005982AGN-751
05414734005975AGFN-756
05414734005869AGN-751
05414734005852AGFN-756

Trademark Results [SJM Regent]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SJM REGENT
SJM REGENT
76440706 2736360 Live/Registered
St. Jude Medical, Inc.
2002-08-15
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.