| Primary Device ID | 00858000003008 |
| NIH Device Record Key | 23f92d19-1900-417f-b32a-4b72d543fd8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SynCardia temporary Total Artificial Heart System |
| Version Model Number | 500101-001 |
| Company DUNS | 080414145 |
| Company Name | SYNCARDIA SYSTEMS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 | 8667719437 |
| xx@xx.xx |
| Device Size Text, specify | 0 |
| Handling Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Handling Environment Temperature | Between 20 Degrees Celsius and 27 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00858000003008 [Primary] |
| LOZ | Artificial Heart |
| 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 | 2015-10-23 |
| 00858000003008 - SynCardia temporary Total Artificial Heart System | 2018-07-06 |
| 00858000003008 - SynCardia temporary Total Artificial Heart System | 2018-07-06 |
| 00858000003077 - SynCardia Companion Rechargeable LI-ION Battery | 2018-07-06 |
| 00858000003084 - SynCardia Freedom® Onboard Battery | 2018-07-06 |
| 00858000003107 - SynCardia Companion 2 Driver | 2018-07-06 |
| 00858000003114 - SynCardia Hand Pump | 2018-07-06 |
| 00858000003121 - SynCardia Freedom® Driver | 2018-07-06 |