| Primary Device ID | 00850033615067 |
| NIH Device Record Key | 502c6adc-8509-4de8-98bd-639deb8f7b44 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ARTEK PRO-01 |
| Version Model Number | 0P9PTATP01UNVWRC01 |
| Catalog Number | 0P9PTATP01UNVWRC01 |
| Company DUNS | 847899911 |
| Company Name | THERMOTEK, INC. |
| 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 | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850033615067 [Primary] |
| ILO | Pack, Hot Or Cold, Water Circulating |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-03-09 |
| Device Publish Date | 2023-03-01 |
| 00850033615005 - Evolution 2 | 2023-08-30 Evolution, DVT, EV0001, Qty 1 |
| 00850033615012 - ARTEK SPORT-01 w UNIV-01, Qty 1 | 2023-03-09 ARTEK SPORT-01 w UNIV-01, Qty 1 |
| 00850033615036 - ArTek Sport Wrap | 2023-03-09 Wrap, ArTek Sport,Univ-01,Qty 1 |
| 00850033615050 - ARTEK PRO-01 WRAP | 2023-03-09 WRAP, ARTEK PRO-01, UNV COMP01 |
| 00850033615067 - ARTEK PRO-01 | 2023-03-09ARTEK PRO-01 W/UNV WRAP, COMP01 |
| 00850033615067 - ARTEK PRO-01 | 2023-03-09 ARTEK PRO-01 W/UNV WRAP, COMP01 |
| B5850P9PT09SYS0 - PT9 | 2019-03-12 PT9 Therapy System |
| B5850P9PTVT4000 - VascuTherm4 | 2019-03-12 VascuTherm4 Therapy System |
| B5850P9PTVT5000 - VascuTherm5 | 2019-03-12 VascuTherm5 Therapy System |