| Primary Device ID | 30815236020132 |
| NIH Device Record Key | 3ea86e60-a982-444d-a533-f2d417a951c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Crystaline II |
| Version Model Number | 5101-II |
| Catalog Number | 5101-II |
| 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 | 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 | 10815236020138 [Primary] |
| GS1 | 20815236020135 [Package] Contains: 10815236020138 Package: Bag [25 Units] In Commercial Distribution |
| GS1 | 30815236020132 [Package] Contains: 20815236020135 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 40815236020139 [Package] Contains: 10815236020138 Package: Bag [100 Units] In Commercial Distribution |
| GS1 | 50815236020136 [Package] Contains: 40815236020139 Package: Box [1000 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 |
| 20815236020166 | Crystaline II Liquid Crystal Temperature Trend Indicators - Dispenser of 5 |
| 10815236020152 | Crystaline II Liquid Crystal Temperature Trend Indicators - Poly Bag of 2 |
| 30815236020132 | Crystaline II Liquid Crystal Temperature Trend Indicators - Envelope of 1 |
| 10815236020121 | Crystaline II Liquid Crystal Temperature Trend Indicators - Box of 125 |
| 20815236020111 | Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 125 |
| 20815236020104 | Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100 |
| 20815236020098 | Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 50 |
| 20815236020081 | Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 25. |
| 00815236020100 | Crystaline II Liquid Crystal Temperature Trend Indicator - Dispenser of 100 - CE Marked |