| Primary Device ID | 04059237000372 |
| NIH Device Record Key | 19f9b789-f65b-4e7f-891d-a308dc1134cb |
| Commercial Distribution Discontinuation | 2020-01-01 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | HEP |
| Version Model Number | HEP with HEYEX 2 SW V3.2c |
| Company DUNS | 329833875 |
| Company Name | Heidelberg Engineering GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | true |
| 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 |