| Primary Device ID | 10885017000314 |
| NIH Device Record Key | 5e3b46a1-b78e-4d69-b3a3-d6476b319888 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FortisCare Blood Glucose Test Strip |
| Version Model Number | EasyMax T1 Pro |
| 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885017000317 [Primary] |
| GS1 | 10885017000314 [Package] Contains: 00885017000317 Package: carton [150 Units] In Commercial Distribution |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-07 |
| Device Publish Date | 2020-01-30 |
| 10885017000260 - FortisCare Blood Glucose Test Strip | 2021-04-26 25 strips in a vial. |
| 10885017000277 - 25 EasyMax FTS Set EN-ES | 2020-12-18 The EASY MAX Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples |
| 10885017000284 - 25 EasyMax 15 FTS Set EN-ES | 2020-12-18 The EASY MAX 15 Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samp |
| 10885017000550 - EasyMax NHCS Set EN | 2020-07-01 1 bottle of Level 2 Solution |
| 10885017000567 - EasyMax 15 NHCS Set EN | 2020-07-01 a bottle of level 2 control solution |
| 01885017000101 - EasyMax LTC Self-Monitoring Blood Glucose System | 2020-06-23 Semi kit: one blood glucose meter |
| 10885017000307 - FortisCare Self-Monitoring Blood Glucose System | 2020-02-07 1 blood glucose meter |
| 10885017000314 - FortisCare Blood Glucose Test Strip | 2020-02-0750 strips in a vial |
| 10885017000314 - FortisCare Blood Glucose Test Strip | 2020-02-07 50 strips in a vial |