| Primary Device ID | 05414734500463 |
| NIH Device Record Key | 006eb858-8031-49b2-859c-5a237c3c4bda |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SJM™ |
| Version Model Number | 442-2 |
| Catalog Number | 442-2 |
| 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 |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 23 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05414734500463 [Primary] |
| LWS | Implantable cardioverter defibrillator (non-CRT) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2020-05-04 |
| Device Publish Date | 2017-04-10 |