| Primary Device ID | 05415067020864 |
| NIH Device Record Key | dd85909e-b4e4-4d58-82de-dfcb9d4bd5c9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | St. Jude Medical Infinity™ |
| Version Model Number | DBS System |
| Catalog Number | 6373 |
| 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 | true |
| Lot Batch | false |
| 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 |
| Phone | +1(855)478-5833 |
| customerservice@sjm.com |
| Special Storage Condition, Specify | Between 0 and 0 *Store components and their packaging where they will not come in contact with liquids of any kind. |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05415067020864 [Primary] |
| MHY | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-29 |
| 05415067030351 | 8CH Flex Extn, 60 cm |
| 05415067030344 | 8CH Flex Extn, 50 cm |
| 05415067030337 | 8CH Directional Lead, 40 cm, 1.5 |
| 05415067030320 | 8CH Directional Lead, 40 cm, 0.5 |
| 05415067030313 | 8CH Directional Lead, 30 cm, 1.5 |
| 05415067030306 | 8CH Directional Lead, 30 cm, 0.5 |
| 05415067020864 | 8CH Flex Extn, 90 cm |
| 05415067020857 | 8CH Flex Extn, 60 cm |
| 05415067020703 | 8CH Directional Lead, 40 cm, 1.5 |
| 05415067020697 | 8CH Directional Lead, 40 cm, 1.5 |
| 05415067020680 | 8CH Directional Lead, 40 cm, 0.5 |
| 05415067020673 | 8CH Directional Lead, 40 cm, 0.5 |
| 05415067020666 | 8CH Directional Lead, 30 cm, 1.5 |
| 05415067020659 | 8CH Directional Lead, 30 cm, 1.5 |
| 05415067020642 | 8CH Directional Lead, 30 cm, 0.5 |
| 05415067020635 | 8CH Directional Lead, 30 cm, 0.5 |
| 05415067020307 | 8CH Flex Extn, 50 cm |