EnSite™ H421020

GUDID 05414734210201

EP-WorkMate RecordConnect

ST. JUDE MEDICAL, INC.

Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Cardiac mapping system Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable Electrical-only medical device connection adaptor, reusable
Primary Device ID05414734210201
NIH Device Record Key322a52d2-ae45-41da-91bc-47b03a3e1792
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnSite™
Version Model NumberVelocity
Catalog NumberH421020
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
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.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry.

Device Identifiers

Device Issuing AgencyDevice ID
GS105414734210201 [Primary]

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-20
Device Publish Date2020-07-10

On-Brand Devices [EnSite™]

05415067026200Software Upgrade Kit, 30 day license, v.2.0
05415067026194Software Upgrade Kit, v.2.0
05415067026163Module, 30 day trial, v.1.0
05415067026132Module, v.1.0
05415067024909Noise Reduction Transformer, 100V
05415067024848Noise Reduction Transformer, 120V
05415067024831Noise Reduction Transformer, 240V
05415067014856Software Upgrade Kit
05415067014573Amplifier and Display Workstation
05415067012173GenConnect Kit Stockert
05415067005861Kit
05415067003867Software Upgrade Kit
05415067003027Software Installation
05415067002952Catheter Catalog Installation
05415067002938Catheter Catalog Installation
05415067002921Catheter Catalog Installation
05415067001863Software Installation
05415067001856Software Upgrade Kit v.3.1
05415067001054Display Workstation (DWS)
05415067000910Display Workstation
05414734219211Software Upgrade Kit v.3.0.1.1
15414734215661Multi-electrode Diagnostic Catheter
05414734214841Fusion™ Module
05414734214636Fusion™ Module
05414734214469Ablation Cable Kit, IBI,T9
0541473421373875-04630-002
05414734213684Velocity™
05414734213660Velocity™
05414734211246Amplifier Kit
05414734211239Display Workstation Kit
05414734210942US Power Kit
05414734210713Amplifier
05414734210614Amplifier Kit
05414734210522GenConnect Kit IBI
05414734210492RecordConnect Kit Universal
05414734210188Module
05415067000026Kit, GenConnect, Stockert, NST
05414734210690RecordConnect
05414734210546GenConnect
05415067033185Software License
05415067003041DWS Kit
05414734210553GenConnect
05414734210218RecordConnect
05414734210201EP-WorkMate RecordConnect
05414734210195RecordConnect
05414734210706Module
05414734209953Module
05415067033789Recording System Connector
05415067032300Locating Electrodes
05415067031402System Reference Electrode

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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