| Primary Device ID | B172OTH10 |
| NIH Device Record Key | e9e502f2-59ff-41e4-9f8a-753a47dc5ea0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OCuSOFT Thermal 1-Touch |
| Version Model Number | OCuSOFT Thermal 1-Touch |
| Company DUNS | 080250040 |
| Company Name | DIGITAL HEAT CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B172OTH10 [Primary] |
| IRT | Pad, Heating, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-09-20 |
| Device Publish Date | 2019-10-10 |
| B172OTH10 - OCuSOFT Thermal 1-Touch | 2021-09-20OCuSOFT Thermal 1-Touch Ophthalmic Warmer |
| B172OTH10 - OCuSOFT Thermal 1-Touch | 2021-09-20 OCuSOFT Thermal 1-Touch Ophthalmic Warmer |
| B172TH10 - Thernal 1-Touch | 2019-09-13 Thermal 1-Touch Ophthalmic Warmer |
| B172PRO0 - Heated Eye Pad Pro | 2019-04-23 Ophthalmic warmer with timer |
| B172SC10 - Scorpion 1-Touch | 2018-09-07 Scorpion Compress Ophthalmic Warmer |
| B172HEP10 - Heated Eye Pad | 2018-03-29 Heated Eye Pad Ophthalmic Warmer |