| Primary Device ID | 00815236020391 |
| NIH Device Record Key | 86acbff4-9b0e-4f6b-b72a-eb907004e49b |
| Commercial Distribution Discontinuation | 2017-05-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | FeverScan Ultra |
| Version Model Number | BFT55U |
| Catalog Number | BFT55U |
| Company DUNS | 059247507 |
| Company Name | LCR HALLCREST, LLC. |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 1-847-998-8580 |
| orders@hallcrest.com |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815236020391 [Direct Marking] |
| GS1 | 10815236020398 [Primary] |
| GS1 | 20815236020395 [Package] Contains: 10815236020398 Package: Poly Bag [5 Units] Discontinued: 2017-05-09 Not in Commercial Distribution |
| KPD | Strip, Temperature, Forehead, Liquid Crystal |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-02-24 |
| Device Publish Date | 2016-09-23 |
| 00815236020919 | Reusable Forehead Thermometer |
| 00815236020391 | FeverScan Ultra Reusable Forehead Thermometer |
| 00815236021039 | Reusable Liquid Crystal Forehead Thermometer - 12 Event, Celsius only with Blank Tabs |
| 00815236021022 | Reusable Liquid Crystal Forehead Thermometer - 12 Event, Dual Scale, with Blank Tabs |