| Primary Device ID | 10029431000004 |
| NIH Device Record Key | 16fe4d1a-aee2-439a-8fcf-fad52b4919b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Temp-n-Toss |
| Version Model Number | C-8735 |
| Company DUNS | 004200824 |
| Company Name | AMERICAN THERMAL INSTRUMENTS, INC. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00029431000007 [Primary] |
| GS1 | 00029431005040 [Package] Contains: 00029431000007 Package: roll [5000 Units] In Commercial Distribution |
| GS1 | 10029431000004 [Package] Contains: 00029431000007 Package: case [67200 Units] In Commercial Distribution |
| GS1 | 20029431000001 [Package] Contains: 00029431000007 Package: roll [5000 Units] In Commercial Distribution |
| KPD | Strip, Temperature, Forehead, Liquid Crystal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-19 |
| Device Publish Date | 2020-08-11 |
| 00029431000021 - ATI, Inc. | 2021-01-06 Reusable Forehead Thermometer |
| 00029431000038 - ATI, Inc. | 2021-01-06 Reusable Forehead Thermometer |
| 00029431000045 - ATI, Inc. | 2021-01-06 Disposable Forehead Thermometer |
| 00029431000014 - ATI, Inc. | 2020-10-08 Disposable Forehead Thermometer |
| 00029431001066 - ATI, Inc. | 2020-10-08 Reusable Forehead Thermometer |
| 00029431004982 - ATI, Inc. | 2020-10-08 Reusable Forehead Thermometer |
| 00029431006559 - ATI, Inc. | 2020-10-08 Reusable Forehead Thermometer |
| 10029431000004 - Temp-n-Toss | 2020-08-19Disposable Forehead Thermometer |
| 10029431000004 - Temp-n-Toss | 2020-08-19 Disposable Forehead Thermometer |