EnSite Precision™ H702474
GUDID 05415067026316
Bedrail Mount Kit
ST. JUDE MEDICAL, INC.
Cardiac mapping system Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount Medical device storage mount| Primary Device ID | 05415067026316 |
| NIH Device Record Key | f87710a1-4230-494e-8a8f-809a20471f33 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnSite Precision™ |
| Version Model Number | H702474 |
| Catalog Number | H702474 |
| 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 | true |
| Serial Number | false |
| 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 |
Customer Support Contacts
| 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 | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com | |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Do not use if packaging is damaged. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067026316 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160210
FDA Product Code
| DQK | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2016-12-20 |
On-Brand Devices [EnSite Precision™]
| 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 |
Trademark Results [EnSite Precision]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENSITE PRECISION 85857159 4526823 Live/Registered |
ST. JUDE MEDICAL, ATRIAL FIBRILLATION DIVISION, INC. 2013-02-22 |
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