SJM Regent™ AG-RHR

GUDID 05414734009256

ST. JUDE MEDICAL, INC.

Heart valve prosthesis holder, single-use
Primary Device ID05414734009256
NIH Device Record Key4c5ae453-9cf2-48c8-90c4-d61a23ece2f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSJM Regent™
Version Model NumberMechanical Heart Valve
Catalog NumberAG-RHR
Company DUNS149818952
Company NameST. JUDE MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
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
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
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
Phone+1(855)478-5833
Emailcustomerservice@sjm.com
Phone+1(855)478-5833
Emailcustomerservice@sjm.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.
Special Storage Condition, SpecifyBetween 0 and 0 *May store indefinitely.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734009256 [Primary]
GS105415067042279 [Primary]

FDA Product Code

DTJHOLDER, HEART-VALVE, PROSTHESIS

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


[05414734009256]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-12-04

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

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