| Primary Device ID | D831PMMONOA398X200 |
| NIH Device Record Key | ba4a500c-3e4d-4827-a045-0e78a027d778 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIOtemp |
| Version Model Number | Pm-Mono-A3-98x20 |
| Company DUNS | 153454736 |
| Company Name | PRIMOTEC LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |