EnSite Precision™ PRCN-SEK-A
GUDID 05415067032355
Surface Electrode Kit
ST. JUDE MEDICAL, INC.
Cardiac mapping system reference patch| Primary Device ID | 05415067032355 |
| NIH Device Record Key | e7b2c654-5ec2-4cd3-9cd6-07717d02efda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EnSite Precision™ |
| Version Model Number | PRCN-SEK-A |
| Catalog Number | PRCN-SEK-A |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067032355 [Primary] |
| GS1 | 15415067032352 [Package] Package: [5 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K201181
FDA Product Code
| DQK | Computer, diagnostic, programmable |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-30 |
| Device Publish Date | 2020-07-22 |
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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