| Primary Device ID | 10815236020374 |
| NIH Device Record Key | 173303ee-a5cc-41be-9c53-eeb32738661f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spiras |
| Version Model Number | 18866 |
| Catalog Number | 18866 |
| Company DUNS | 059247507 |
| Company Name | LCR HALLCREST, LLC. |
| Device Count | 100 |
| 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 |
| Storage Environment Temperature | Between 60 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815236020377 [Unit of Use] |
| GS1 | 10815236020374 [Primary] |
| 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 |
| 10815236020374 | 7 Event Horizontal Temperature Trend Indicator |
| 10815236020367 | 6 Event Horizontal Temperature Trend Indicator |
| 10815236020350 | 11 Event Horizontal Temperature Trend Indicator |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPIRAS 76066563 not registered Dead/Abandoned |
Spiras Corporation 2000-06-09 |