| Primary Device ID | 00815236020629 |
| NIH Device Record Key | a2d3eb1f-39b0-4a86-9ccf-00354a7303e0 |
| Commercial Distribution Discontinuation | 2017-05-09 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | FeverScan Ultra Reusable |
| Version Model Number | PFT55U |
| Catalog Number | PFT55U |
| 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 |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815236020629 [Direct Marking] |
| GS1 | 10815236020626 [Primary] |
| GS1 | 20815236020623 [Package] Contains: 10815236020626 Package: Blister Pack [1 Units] Discontinued: 2017-05-09 Not in Commercial Distribution |
| GS1 | 30815236020620 [Package] Contains: 20815236020623 Package: Poly Bag [12 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 | 2016-09-24 |
| 20815236021057 - HemoTemp | 2022-06-28 Blood Bag Temperature Monitor |
| 20815236021071 - TempTrend II | 2022-06-28 |
| 20815236021101 - StaFreez | 2022-06-28 |
| 20815236021132 - LabTemp 40 | 2022-06-28 |
| 10815236020923 - HemoTemp II Activator | 2022-06-24 |
| 20815236021125 - LabTemp 20 | 2022-06-24 |
| 20815236020173 - Crystaline® Moving Line | 2022-03-09 Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 100 |
| 20815236020180 - Crystaline® Moving Line | 2022-03-09 Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 50 |