Fore Health GAL05Ex-PK/BC
GUDID 14719883871371
FORTECHGRP CO., LTD.
Intermittent electronic patient thermometer| Primary Device ID | 14719883871371 |
| NIH Device Record Key | 5a9f662d-5d04-4cd4-8650-3f7187f30e82 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Fore Health |
| Version Model Number | GAL05Ex-XX/BC |
| Catalog Number | GAL05Ex-PK/BC |
| 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 | 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 | false |
Operating and Storage Conditions
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04719883871374 [Primary] |
| GS1 | 14719883871371 [Package] Contains: 04719883871374 Package: box [10 Units] In Commercial Distribution |
FDA Product Code
| SDV | Clinical Electronic Thermometer |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
On-Brand Devices [Fore Health]
| 14719883871432 | ACT8000-TX |
| 14719883871388 | Fore Health Smart Thermometer |
| 14719883871371 | GAL05Ex-XX/BC |
| 14719883871357 | Forehead and Ear Infrared Thermometer |
Trademark Results [Fore Health]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FORE HEALTH 75748902 not registered Dead/Abandoned |
Capitol Physical Therapy Center 1999-07-13 |
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