| Primary Device ID | 15415067042313 |
| NIH Device Record Key | 9fde485c-a7a1-4f63-8495-26f2e7b19786 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | LT100 |
| Catalog Number | LT100 |
| Company DUNS | 149818952 |
| Company Name | ST. JUDE MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067004772 [Previous] |
| GS1 | 05415067042316 [Primary] |
| GS1 | 15415067042313 [Package] Contains: 05415067042316 Package: [20 Units] In Commercial Distribution |
| LXN | PROBE, TEST, HEART-VALVE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-05-29 |
| Device Publish Date | 2023-05-19 |
| 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 |