| Primary Device ID | 05414734500449 |
| NIH Device Record Key | f5f33060-9a98-4a42-8592-dd971da926e3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM™ |
| Version Model Number | 424 |
| Catalog Number | 424 |
| Company DUNS | 790268031 |
| 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 | true |
| 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 |
| Storage Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between -5 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734500449 [Primary] |
| KRG | Programmer, pacemaker |
| 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 | 2017-04-10 |