Masters Series™ 19CAVGJ-514 00

GUDID 05415067044037

Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft

ST. JUDE MEDICAL, INC.

Aortic bi-leaflet mechanical heart valve prosthesis/biologic-polymer aorta graft
Primary Device ID05415067044037
NIH Device Record Key52e6ac0f-46af-443d-9025-c3592860cf88
Commercial Distribution StatusIn Commercial Distribution
Brand NameMasters Series™
Version Model Number19CAVGJ-514 00
Catalog Number19CAVGJ-514 00
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
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 Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter
Outer Diameter19 Millimeter

Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734005906 [Previous]
GS105415067044037 [Primary]

FDA Product Code

LWQHEART-VALVE, MECHANICAL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-26
Device Publish Date2024-12-18

On-Brand Devices [Masters Series™]

05415067042255Replacement Holder/Rotators
05415067042231Replacement Holder/Rotators
05415067044099Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
05415067044037Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft
05415067043696Aortic Valved Graft with Hemashield Graft technology Mechanical Valved Graft

Trademark Results [Masters Series]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MASTERS SERIES
MASTERS SERIES
90825185 not registered Live/Pending
St. Jude Medical, LLC
2021-07-13
MASTERS SERIES
MASTERS SERIES
85220632 not registered Dead/Abandoned
XR, LLC
2011-01-19
MASTERS SERIES
MASTERS SERIES
78614211 not registered Dead/Abandoned
Legendary Sound International Ltd.
2005-04-21
MASTERS SERIES
MASTERS SERIES
77242752 3425852 Live/Registered
Haworth, Inc.
2007-07-31
MASTERS SERIES
MASTERS SERIES
77235946 not registered Dead/Abandoned
Pearl Corporation
2007-07-23
MASTERS SERIES
MASTERS SERIES
76378542 2725753 Live/Registered
ENQUATICS, INC.
2002-03-05
MASTERS SERIES
MASTERS SERIES
74353374 1892650 Dead/Cancelled
Pearl Corporation
1993-01-28

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