Primary Device ID | 15415067025934 |
NIH Device Record Key | 77318a4e-07ae-42d0-b210-6b079c9a1d75 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EnSite Precision™ |
Version Model Number | EN0020-P |
Catalog Number | EN0020-P |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
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 |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05415067025937 [Primary] |
GS1 | 15415067025934 [Package] Contains: 05415067025937 Package: [5 Units] In Commercial Distribution |
DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-07-22 |
Device Publish Date | 2016-12-20 |
05415067030382 | Adjustable Field Frame Bracket |
05415067030085 | Software Installation |
05415067027580 | Extended Field Frame Bracket |
05415067027528 | Field Frame Storage Bracket |
05415067026316 | Bedrail Mount Kit |
05415067026309 | Power Supply Kit |
05415067026279 | Software Installation, v.1.0.1 |
05415067026125 | Software Installation, v.2.0.0 |
05415067026118 | Software Installation, 30 day trial, v.2.0.0 |
15415067025934 | Surface Electrode Kit |
05415067025265 | Patient Reference Sensor |
05415067024756 | Link |
05415067024725 | Field Frame Bracket |
05415067024718 | Field Frame Cable |
05415067024701 | Module |
05415067024695 | Field Frame |
05415067025937 | Surface Electrode Kit |
05415067033178 | Software Installation |
05415067032355 | Surface Electrode Kit |
05415067024732 | Module |
15415067041712 | Surface Electrode Kit |
05415067046185 | Software Upgrade |
05415067035004 | Software Installation |
05415067046802 | Software Upgrade |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ENSITE PRECISION 85857159 4526823 Live/Registered |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2013-02-22 |