| Primary Device ID | 30815112020584 |
| NIH Device Record Key | aceeea7d-615d-41c2-b12f-889ebf09f3bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HeartSee Cardiac PET Processing Software |
| Version Model Number | 1.00 |
| Catalog Number | 001771 |
| Company DUNS | 849234661 |
| Company Name | Bracco Diagnostics 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 | 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 | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com | |
| Phone | 800-447-6883 |
| bracco.otc@diag.bracco.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30815112020584 [Primary] |
| KPS | System, Tomography, Computed, Emission |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2025-05-26 |
| Device Publish Date | 2019-07-29 |
| 30815112020584 | Cardiac PET Processing Software |
| 30815112021543 | Cardiac PET Processing Software |