BurstDR™ 3857
GUDID 05415067028709
Patient Programmer
ST. JUDE MEDICAL, INC.
Multiple active implantable device programmer| Primary Device ID | 05415067028709 |
| NIH Device Record Key | 7838e46d-820f-40a0-98f2-b20990a57ce6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BurstDR™ |
| Version Model Number | Stimulation Temp Evaluation |
| Catalog Number | 3857 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 |
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 | |
| 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 Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 150 KiloPascal |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067028709 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P010032
FDA Product Code
| LGW | Stimulator, spinal-cord, totally implanted for pain relief |
| NMD | OXIMETER, TISSUE SATURATION, REPROCESSED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2018-03-15 |
Devices Manufactured by ST. JUDE MEDICAL, INC.
| 05415067038470 - Epic™ | 2025-10-07 Max Heart Valve Sizer Set For Use With Epic™ Max |
| 05415067049070 - Epic™ | 2025-10-06 Heart Valve Sizer Set |
| 05415067051158 - EnSite™ | 2025-09-23 X EP System AutoMark Index Temporary Software License |
| 05415067051172 - EnSite™ | 2025-09-23 X EP System AutoMark Index Software License |
| 05414734219136 - EP-4™ | 2025-09-19 Cardiac Stimulator Keyboard |
| 05415067002709 - EP-4™ | 2025-09-19 Cardiac Stimulator Cardiac Stimulator Cable |
| 05415067007865 - EP-4™ | 2025-09-19 Cardiac Stimulator Cardiac Stimulator Cable |
| 05415067007872 - EP-4™ | 2025-09-19 Cardiac Stimulator Cardiac Stimulator Cable |
Trademark Results [BurstDR]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BURSTDR 87043599 5351398 Live/Registered |
St. Jude Medical, Inc. 2016-05-19 |
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