| Primary Device ID | 00813024013419 |
| NIH Device Record Key | 886f0381-3271-4755-b813-ea2c646d560b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TLC-II SYSTEM BATTERY CHARGER |
| Version Model Number | 20010-2820-000 |
| Catalog Number | 20010-2820-000 |
| Company DUNS | 070156955 |
| Company Name | Thoratec Corporation |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813024013419 [Primary] |
| DSQ | Ventricular (Assisst) Bypass |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2014-09-20 |
| 05415067038784 - HeartMate 3™ | 2025-07-29 Mini Apical Cuff Kit |
| 05415067039446 - HeartMate 3™ | 2025-07-29 System Controller |
| 05415067039880 - HeartMate™ | 2025-07-29 11 Volt Li-Ion Backup Battery |
| 05415067039903 - HeartMate™ GoGear™ | 2025-07-29 Wearable Accessories Kit |
| 05415067039422 - HeartMate 3™ | 2025-07-24 System Controller Low Flow 2.0 |
| 15415067037807 - HeartMate™ | 2025-05-26 14V Li-ion Rechargeable Battery Set |
| 05415067037824 - HeartMate™ | 2025-05-26 Universal Battery Charger |
| 05415067038173 - HeartMate™ GoGear™ | 2025-05-26 Shower Bag |