| Primary Device ID | 14719883870077 |
| NIH Device Record Key | 1688faf2-e00c-487e-8669-5c8dfc62f2d1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ForeHealth |
| Version Model Number | GAL01 Ex-XX |
| Catalog Number | GAL01 Ex-WH |
| Company DUNS | 657259669 |
| Company Name | FORTECHGRP CO., LTD. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
|---|---|
| GS1 | 04719883870070 [Primary] |
| GS1 | 14719883870077 [Package] Contains: 04719883870070 Package: box [10 Units] In Commercial Distribution |
| SDV | Clinical Electronic Thermometer |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-03 |
| Device Publish Date | 2026-01-26 |
| 14719883871357 - Fore Health | 2026-02-05 Forehead and Ear Infrared Thermometer |
| 14719883871371 - Fore Health | 2026-02-05 |
| 14719883871388 - Fore Health | 2026-02-05 Fore Health Smart Thermometer |
| 14719883871432 - Fore Health | 2026-02-05 |
| 14719883870077 - ForeHealth | 2026-02-03The product is used to measure person's human body temperature at hospital and home. It is used for the temperature measurement of oral, armpit and anus. |
| 14719883870077 - ForeHealth | 2026-02-03 The product is used to measure person's human body temperature at hospital and home. It is used for the temperature measurement |