| Primary Device ID | 00681131304863 |
| NIH Device Record Key | 215d2f11-b06a-4575-bb52-706f97cd61a8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Equate Blood Glucose Test Strips |
| Version Model Number | 038600 |
| Catalog Number | 038600 |
| Company DUNS | 043251054 |
| Company Name | UNISTRIP TECHNOLOGIES, LLC |
| Device Count | 50 |
| 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 | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a dry place between 39°F - 104°F (4°C - 40°C) and between 10% - 90% R.H. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00068113004862 [Unit of Use] |
| GS1 | 00681131104869 [Primary] |
| GS1 | 00681131304863 [Package] Contains: 00681131104869 Package: Corrugated Carton [24 Units] Discontinued: 2020-02-05 Not in Commercial Distribution |
| GS1 | 10681131104866 [Package] Contains: 00681131104869 Package: Corrugated Carton [24 Units] In Commercial Distribution |
| GS1 | 30681131104860 [Package] Contains: 00681131104869 Package: Vial [1 Units] In Commercial Distribution |
| NDC/NHRIC | 49035-0386-00 [Secondary] |
| GS1 | 90681131104862 [Unit of Use] |
| 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 | 2020-02-06 |
| Device Publish Date | 2016-09-24 |
| 00681131304863 - Equate Blood Glucose Test Strips | 2020-02-06Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016. |
| 00681131304863 - Equate Blood Glucose Test Strips | 2020-02-06 Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before Ap |
| 00389167348508 - UniStrip1 Generic Blood Glucose Test Strip | 2018-03-29 UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchase |
| 00389167262101 - UniStrip Control Solution Low | 2018-03-29 UniStrip Control Solution Low 4mL |