Primary Device ID | 05415067012173 |
NIH Device Record Key | b2d3b760-1e7d-4181-9735-325ad611470f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Ensite™ |
Version Model Number | Velocity™ |
Catalog Number | H701217 |
Company DUNS | 149818952 |
Company Name | ST. JUDE MEDICAL, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com | |
Phone | +1(855)478-5833 |
customerservice@sjm.com |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if package is damaged. |
Handling Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -25 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067012173 [Primary] |
DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-04-21 |
05415067026200 | Software Upgrade Kit, 30 day license, v.2.0 |
05415067026194 | Software Upgrade Kit, v.2.0 |
05415067026163 | Module, 30 day trial, v.1.0 |
05415067026132 | Module, v.1.0 |
05415067024909 | Noise Reduction Transformer, 100V |
05415067024848 | Noise Reduction Transformer, 120V |
05415067024831 | Noise Reduction Transformer, 240V |
05415067014856 | Software Upgrade Kit |
05415067014573 | Amplifier and Display Workstation |
05415067012173 | GenConnect Kit Stockert |
05415067005861 | Kit |
05415067003867 | Software Upgrade Kit |
05415067003027 | Software Installation |
05415067002952 | Catheter Catalog Installation |
05415067002938 | Catheter Catalog Installation |
05415067002921 | Catheter Catalog Installation |
05415067001863 | Software Installation |
05415067001856 | Software Upgrade Kit v.3.1 |
05415067001054 | Display Workstation (DWS) |
05415067000910 | Display Workstation |
05414734219211 | Software Upgrade Kit v.3.0.1.1 |
15414734215661 | Multi-electrode Diagnostic Catheter |
05414734214841 | Fusion™ Module |
05414734214636 | Fusion™ Module |
05414734214469 | Ablation Cable Kit, IBI,T9 |
05414734213738 | 75-04630-002 |
05414734213684 | Velocity™ |
05414734213660 | Velocity™ |
05414734211246 | Amplifier Kit |
05414734211239 | Display Workstation Kit |
05414734210942 | US Power Kit |
05414734210713 | Amplifier |
05414734210614 | Amplifier Kit |
05414734210522 | GenConnect Kit IBI |
05414734210492 | RecordConnect Kit Universal |
05414734210188 | Module |
05415067000026 | Kit, GenConnect, Stockert, NST |
05414734210690 | RecordConnect |
05414734210546 | GenConnect |
05415067033185 | Software License |
05415067003041 | DWS Kit |
05414734210553 | GenConnect |
05414734210218 | RecordConnect |
05414734210201 | EP-WorkMate RecordConnect |
05414734210195 | RecordConnect |
05414734210706 | Module |
05414734209953 | Module |
05415067033789 | Recording System Connector |
05415067032300 | Locating Electrodes |
05415067031402 | System Reference Electrode |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENSITE 97566798 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2022-08-26 |
![]() ENSITE 97566542 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2022-08-26 |
![]() ENSITE 97485966 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2022-07-01 |
![]() ENSITE 90359638 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2020-12-04 |
![]() ENSITE 88911183 not registered Live/Pending |
Sondpex Corporation of America, LLC 2020-05-12 |
![]() ENSITE 88621932 not registered Live/Pending |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2019-09-18 |
![]() ENSITE 87226368 5220019 Live/Registered |
Regal Beloit America, Inc. 2016-11-04 |
![]() ENSITE 86945184 5216282 Live/Registered |
EnSite Incorporated 2016-03-18 |
![]() ENSITE 86143083 4689787 Live/Registered |
St. Jude Medical, Atrial Fibrillation Division, Inc. 2013-12-13 |
![]() ENSITE 78070396 not registered Dead/Abandoned |
JOHNSONDIVERSEY, INC. 2001-06-21 |
![]() ENSITE 77200065 3595574 Dead/Cancelled |
Ensite, LLC 2007-06-07 |
![]() ENSITE 76168859 not registered Dead/Abandoned |
Execon, Inc. 2000-11-20 |