Trifecta™ TFGT-29A

GUDID 05415067018250

Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology

ST. JUDE MEDICAL, INC.

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis
Primary Device ID05415067018250
NIH Device Record Key2d1d071d-2fb5-4498-94c6-ee505cae558b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrifecta™
Version Model NumberTFGT-A
Catalog NumberTFGT-29A
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
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 Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter
Outer Diameter29 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red.
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067018250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWRheart-valve, non-allograft tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-04-27

On-Brand Devices [Trifecta™]

05415067027566Valve Series TF2000-VR Sizer Set
05415067025951Valve Sizer Set
05415067018274Valve Flexible Holder Handle
05415067018267Valve Rigid Holder Handle
05415067018250Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
05415067018243Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
05415067018236Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
05415067018229Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
05415067018212Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
05415067018205Aortic Pericardial Bioprosthetic Heart Valve with Glide™ Technology
0541506700546529mm Sizer
0541506700545827 mm Sizer
0541506700544125 mm Sizer
0541506700543423 mm Sizer
0541506700542721 mm Sizer
0541506700541019 mm Sizer
05414734052078Valve TF2000 Sizer Set
05414734052061TF-A
05414734052054TF-A
05414734052047TF-A
05414734052030TF-A
05414734052023TF-A
05414734052016TF-A

Trademark Results [Trifecta]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRIFECTA
TRIFECTA
98170552 not registered Live/Pending
Bay State Hemp Company
2023-09-08
TRIFECTA
TRIFECTA
97861407 not registered Live/Pending
Mark J. Kohler, CPA, JD, PC
2023-03-28
TRIFECTA
TRIFECTA
97602456 not registered Live/Pending
Trifecta Telephony Pty Ltd.
2022-09-23
TRIFECTA
TRIFECTA
97444837 not registered Live/Pending
Amir M. Karam, M.D, Inc.
2022-06-06
TRIFECTA
TRIFECTA
97311574 not registered Live/Pending
Audiolineout LLC
2022-03-14
TRIFECTA
TRIFECTA
97267101 not registered Live/Pending
Trifecta LLC
2022-02-15
TRIFECTA
TRIFECTA
90636110 not registered Live/Pending
Grove, Amelia
2021-04-09
TRIFECTA
TRIFECTA
90144755 not registered Live/Pending
Nekoosa LV, LLC
2020-08-28
TRIFECTA
TRIFECTA
90070383 not registered Live/Pending
HUBBLY BUBBLY LLC
2020-07-23
TRIFECTA
TRIFECTA
88723305 not registered Live/Pending
RUSSCO57, LLC
2019-12-11
TRIFECTA
TRIFECTA
88676830 not registered Live/Pending
Globus Medical, Inc.
2019-11-01
TRIFECTA
TRIFECTA
88674085 not registered Live/Pending
North American Power Products, Inc.
2019-10-30

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