| Primary Device ID | 00885017000461 |
| NIH Device Record Key | ecef23a2-41e5-4546-8555-28363b93a42f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FortisCare Self-Monitoring Blood Glucose System |
| Version Model Number | EM66 |
| Company DUNS | 658620117 |
| Company Name | EPS BIO TECHNOLOGY CORP. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 866-994-3345 |
| info@epsbio.com.tw |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 40 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885017000461 [Primary] |
| GS1 | 01885017000460 [Package] Package: carton [10 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-05-22 |
| Device Publish Date | 2016-07-24 |
| 00885017000461 | 1 blood glucose meter; 10 strips in a vial; level 2 control solution in a convenience kit |
| 10885017000307 | 1 blood glucose meter |