| Primary Device ID | D831PMMONOA3598X180 |
| NIH Device Record Key | 1471bee6-a376-4d82-a816-a5d6bc4c252f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PREMIOtemp |
| Version Model Number | PM-Mono-A3.5-98x18 |
| 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 |