| Primary Device ID | 20815236020227 |
| NIH Device Record Key | b7eb027d-ebfa-449a-90cc-c96b904d3e34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crystaline W |
| Version Model Number | 5105H |
| Catalog Number | 5105H |
| 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 |
| 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 | 00815236020223 [Unit of Use] |
| GS1 | 10815236020220 [Primary] |
| GS1 | 20815236020227 [Package] Contains: 10815236020220 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 |
| 10815236020237 | Crystaline W Liquid Crystal Temperature Trend Indicator |
| 20815236020227 | Crystaline W Liquid Crystal Temperature Trend Indicator |
| 10815236020213 | Crystaline W Liquid Crystal Temperature Trend Indicator |