| Primary Device ID | 05414734405331 |
| NIH Device Record Key | b05d556f-9130-479b-b3ae-b0e60a5e3e5a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM™ |
| Version Model Number | 2002 |
| Catalog Number | 2002 |
| 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 | 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 |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Temperature | Between 14 Degrees Fahrenheit and 131 Degrees Fahrenheit |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 55 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734405331 [Primary] |
| GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-04-15 |