| Primary Device ID | 00850578007884 |
| NIH Device Record Key | 6298bbde-1d3e-4ce5-85b3-07a73988a10a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HEPRO.US Nitrile Standard Class Series 400 |
| Version Model Number | BX - 400 Nitrile Large |
| Company DUNS | 080061451 |
| Company Name | HEPRO.US INC. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |