Viva™ CRT-P

GUDID 00643169351905

CRT C6TR01 VIVA CRT-P US MR

MEDTRONIC, INC.

Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker Cardiac resynchronization therapy implantable pacemaker
Primary Device ID00643169351905
NIH Device Record Key3a55a46d-29b7-470e-a1ef-7fee9c8060e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameViva™ CRT-P
Version Model NumberC6TR01
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
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(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 0 Degrees Fahrenheit and 131 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169351905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKEPulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-28
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

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00763000902544 - Launcher™2024-06-04 CATHETER LA83DRCSH LA 8F 100CM 3DRC
00763000902551 - Launcher™2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC
00763000902568 - Launcher™2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10

Trademark Results [Viva]

Mark Image

Registration | Serial
Company
Trademark
Application Date
VIVA
VIVA
98511029 not registered Live/Pending
Foley, Denise
2024-04-20
VIVA
VIVA
98294670 not registered Live/Pending
RADIO SYSTEMS CORPORATION
2023-12-01
VIVA
VIVA
98223200 not registered Live/Pending
STARmed Co., Ltd.
2023-10-13
VIVA
VIVA
98072565 not registered Live/Pending
Breuninger, Inc.
2023-07-06
VIVA
VIVA
98052652 not registered Live/Pending
Zoria Viktoriia
2023-06-21
VIVA
VIVA
98025249 not registered Live/Pending
Lian Hwa Foods Corporation
2023-06-02
VIVA
VIVA
97817726 not registered Live/Pending
Tribal Minds, LLC
2023-03-01
VIVA
VIVA
97677393 not registered Live/Pending
Vivacity Labs Limited
2022-11-15
VIVA
VIVA
97631692 not registered Live/Pending
Aryeh Nana S
2022-10-13
VIVA
VIVA
97624892 not registered Live/Pending
VIVA ENTERTAINMENT, LLC
2022-10-09
VIVA
VIVA
97624688 not registered Live/Pending
VIVA ENTERTAINMENT, LLC
2022-10-09
VIVA
VIVA
97453767 not registered Live/Pending
Dymand, Stephen
2022-06-10
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