| Primary Device ID | B133ECTB40 |
| NIH Device Record Key | ada79a9e-c012-4f88-af57-b0d1211c2776 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Emory Cardiac Toolbox |
| Version Model Number | 4.0.5121.18001 |
| Company DUNS | 113727205 |
| Company Name | SYNTERMED INCORPORATED |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B133ECTB40 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-04-07 |
| B133ECTB40 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |
| B133ECTB422102190 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |
| B133ECTB422112080 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |
| B133ECTB42221031 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |
| B133ECTB42231102 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |
| B133ECTB422403260 | The Emory Cardiac Toolbox™ 4.0 is used to display gated wall motion and for quantifying parame |