| Primary Device ID | 05415067045331 |
| NIH Device Record Key | 7728af94-8910-47bb-af1a-f44c08fd7238 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultreon™ |
| Version Model Number | 1015191 |
| Catalog Number | 1015191 |
| 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 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067045331 [Primary] |
| NQQ | SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-12 |
| Device Publish Date | 2022-04-04 |
| 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 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ULTREON 90655110 not registered Live/Pending |
Abbott Cardiovascular Systems, Inc. 2021-04-19 |
![]() ULTREON 90555676 not registered Live/Pending |
Cypress Semiconductor Corporation 2021-03-02 |
![]() ULTREON 88847607 not registered Live/Pending |
Abbott Cardiovascular Systems Inc. 2020-03-25 |
![]() ULTREON 75513740 not registered Dead/Abandoned |
Pfizer Inc. 1998-07-06 |
![]() ULTREON 75513737 not registered Dead/Abandoned |
Pfizer Inc. 1998-07-06 |
![]() ULTREON 74452352 not registered Dead/Abandoned |
Pfizer Inc. 1993-10-29 |
![]() ULTREON 74287066 not registered Dead/Abandoned |
Pfizer Inc 1992-06-22 |
![]() ULTREON 74034511 not registered Dead/Abandoned |
Pfizer Inc 1990-03-05 |