| Primary Device ID | 20815236020319 |
| NIH Device Record Key | 2bc401af-706f-40f8-b594-c45b64d762e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TempAlert II |
| Version Model Number | 8501H-II |
| Catalog Number | 8501H-II |
| Company DUNS | 059247507 |
| Company Name | LCR HALLCREST, LLC. |
| Device Count | 50 |
| 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 | 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 | 1-800-325-3671 |
| mailbox@sharn.com |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815236020315 [Unit of Use] |
| GS1 | 10815236020312 [Primary] |
| GS1 | 20815236020319 [Package] Contains: 10815236020312 Package: Box [50 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 | 2016-09-23 |
| 20815236020340 | TempAlert II Liquid Crystal Temperature Trend Indicator |
| 10815236020336 | TempAlert II Liquid Crystal Temperature Trend Indicator |
| 20815236020326 | TempAlert II Liquid Crystal Temperature Trend Indicator |
| 20815236020319 | TempAlert II Liquid Crystal Temperature Trend Indicator |
| 00815236020322 | TempAlert II Liquid Crystal Temperature Trend Indicator - CE Marked |