| 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 |
| 00850033615227 - Echo Ultrasound Device (PRC) | 2026-03-03 Echo Ultrasound Device, Carton |
| 00850033615258 - Echo Ultrasound Device (PRC) | 2026-03-03 Echo Ultrasound Device, Single |
| 00850033615289 - Echo Ultrasound Device (USA) | 2026-03-03 Echo Ultrasound Device (USA), Carton |
| 00850033615340 - Echo Ultrasound Device (USA) | 2026-03-03 Echo Ultrasound Device (USA), Single |
| 00850033615371 - Echo BOX, DRESSING & GEL POD PACK, USND, PRC | 2026-03-03 Echo BOX, DRESSING & GEL POD PACK, USND, PRC Single |
| 00850033615388 - Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES | 2026-03-03 Echo CTN, DRESSINGS, USND, PRC, QTY 4 BOXES |
| 00850033615425 - Echo Ultra Sound Gel Pods, Carton | 2026-03-03 Echo Ultra Sound Gel Pods, Carton |
| 00850033615487 - Echo Ultra Sound Gel Pod, Single | 2026-03-03 Echo Ultra Sound Gel Pod, Single |