| Primary Device ID | 00859519002391 |
| NIH Device Record Key | fb122ebf-a99b-4a94-a528-e12a4081195a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioTel Care BGM 4 |
| Version Model Number | TM0009 |
| Catalog Number | TM0009 |
| Company DUNS | 116979417 |
| Company Name | TELCARE, LLC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859519002391 [Package] Contains: 00859519002407 Package: [1 Units] In Commercial Distribution |
| GS1 | 00859519002407 [Primary] |
| 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 | 2021-01-25 |
| Device Publish Date | 2021-01-16 |
| 00859519002391 - BioTel Care BGM 4 | 2021-01-25BioTel Care BGM 4 |
| 00859519002391 - BioTel Care BGM 4 | 2021-01-25 BioTel Care BGM 4 |
| 00859519002261 - BioTel Care® Test Strips | 2019-03-19 Test strips for use with BioTel Care® Blood Glucose Meter and BioTel Care® Control Solution. |
| 10859519002053 - BioTel Care® Double Control Solution | 2019-03-19 Double Control Solution for use with BioTel Care® Blood Glucose Meter and Test Strips. |
| 00859519002223 - BioTel Care® Blood Glucose Monitoring System | 2019-03-19 The BioTel Care® Blood Glucose Monitoring System consists of a meter, test strips, and control solutions (Level 1 and Level 2). |
| 00859519002247 - Telserve® Data Management System | 2019-03-19 The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood |