| Primary Device ID | 00815236020612 |
| NIH Device Record Key | 116c1378-67f0-446a-90a4-629311fe89d9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FeverTemp Ultra |
| Version Model Number | PFT55E |
| Catalog Number | PFT55E |
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Optimal Storage and Handling Conditions: 60 to 80°F and 40 to 60% relative humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815236020612 [Direct Marking] |
| GS1 | 10815236020619 [Primary] |
| GS1 | 20815236020616 [Package] Contains: 10815236020619 Package: Blister Pack [1 Units] In Commercial Distribution |
| GS1 | 30815236020613 [Package] Contains: 20815236020616 Package: Poly Bag [12 Units] 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 |
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| 20815236020180 - Crystaline® Moving Line | 2022-03-09 Crystaline® Moving Line Temperature Trend Indicator, Dispenser of 50 |