| Primary Device ID | 00867661000370 |
| NIH Device Record Key | f4a70871-e35f-476c-b042-d75ac6eebe60 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wireless Infrared Thermometer |
| Version Model Number | WIT-10 |
| Company DUNS | 079659378 |
| Company Name | CLOUD DX 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 | false |
| Lot Batch | true |
| 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 |
| Phone | 888-543-0944 |
| regulatory@clouddx.com | |
| Phone | 888-543-0944 |
| regulatory@clouddx.com | |
| Phone | 888-543-0944 |
| regulatory@clouddx.com | |
| Phone | 888-543-0944 |
| regulatory@clouddx.com | |
| Phone | 888-543-0944 |
| regulatory@clouddx.com | |
| Phone | 888-543-0944 |
| regulatory@clouddx.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00867661000370 [Primary] |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-18 |
| Device Publish Date | 2022-05-10 |
| 00867661000370 - Wireless Infrared Thermometer | 2022-05-18 |
| 00867661000370 - Wireless Infrared Thermometer | 2022-05-18 |
| 00867661000356 - Wireless Pulse Oximeter | 2021-11-10 |
| 00867661000318 - Pulsewave Blood Pressure Monitor | 2019-11-08 |
| 00867661000349 - Wireless Pulse Oximeter | 2019-09-26 |