EnSite™ Velocity™ H702495

GUDID 05415067026101

Software Upgrade Kit, v.5.0.2

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software
Primary Device ID05415067026101
NIH Device Record Key1d1e8726-330b-495d-bcc6-0bcb20f52916
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnSite™ Velocity™
Version Model NumberH702495
Catalog NumberH702495
Company DUNS149818952
Company NameST. JUDE MEDICAL, 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 Usefalse
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing AgencyDevice ID
GS105415067026101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKCOMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2016-12-08

On-Brand Devices [EnSite™ Velocity™]

05415067026101Software Upgrade Kit, v.5.0.2
05415067023230Utility Upgrade Kit
05415067012258GenConnect
05415067008718Workstation Accessory Kit
05415067001061DWS Kit
05414734031035Workstation

Trademark Results [EnSite]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENSITE
ENSITE
97566798 not registered Live/Pending
St. Jude Medical, Atrial Fibrillation Division, Inc.
2022-08-26
ENSITE
ENSITE
97566542 not registered Live/Pending
St. Jude Medical, Atrial Fibrillation Division, Inc.
2022-08-26
ENSITE
ENSITE
97485966 not registered Live/Pending
St. Jude Medical, Atrial Fibrillation Division, Inc.
2022-07-01
ENSITE
ENSITE
90359638 not registered Live/Pending
St. Jude Medical, Atrial Fibrillation Division, Inc.
2020-12-04
ENSITE
ENSITE
88911183 not registered Live/Pending
Sondpex Corporation of America, LLC
2020-05-12
ENSITE
ENSITE
88621932 not registered Live/Pending
St. Jude Medical, Atrial Fibrillation Division, Inc.
2019-09-18
ENSITE
ENSITE
87226368 5220019 Live/Registered
Regal Beloit America, Inc.
2016-11-04
ENSITE
ENSITE
86945184 5216282 Live/Registered
EnSite Incorporated
2016-03-18
ENSITE
ENSITE
86143083 4689787 Live/Registered
St. Jude Medical, Atrial Fibrillation Division, Inc.
2013-12-13
ENSITE
ENSITE
78070396 not registered Dead/Abandoned
JOHNSONDIVERSEY, INC.
2001-06-21
ENSITE
ENSITE
77200065 3595574 Dead/Cancelled
Ensite, LLC
2007-06-07
ENSITE
ENSITE
76168859 not registered Dead/Abandoned
Execon, Inc.
2000-11-20

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