MyGlucoHealth® BT Meter
GUDID 00852668007095
Blood Glucose meter (label)
ENTRA HEALTH SYSTEMS LLC
Glucose monitoring system IVD, home-use| Primary Device ID | 00852668007095 |
| NIH Device Record Key | 5069332c-b8da-4717-9816-915de6055cd6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyGlucoHealth® BT Meter |
| Version Model Number | MGH-BT1 |
| Company DUNS | 826314044 |
| Company Name | ENTRA HEALTH SYSTEMS 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com | |
| Phone | 619-684-6232 |
| support@entrahealth.com |
Device Dimensions
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
| Total Volume | 0.3 Microliter |
Operating and Storage Conditions
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852668007095 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081703
FDA Product Code
| NBW | System, Test, Blood Glucose, Over The Counter |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-02-05 |
| Device Publish Date | 2017-01-27 |
Devices Manufactured by ENTRA HEALTH SYSTEMS LLC
| 10850081003011 - MyGlucoHealth Test Strips | 2021-10-28 Glucose Test Strip Vial Label |
| 10852668007016 - BLE Smart Test Strip | 2021-10-28 BLE Smart Test Strip Vial |
| 00852668007187 - BLE Smart® Control Solution | 2019-02-22 Control Solution Box 3 Pack |
| 00850081003960 - BLE Smart® Test Strips | 2019-02-08 Glucose Test Strips |
| 00852668007019 - BLE Smart® Test Strips | 2019-02-05 Glucose Test Strips Unit of Use (each individual test strip) |
| 00852668007064 - BLE Smart® Blood Glucose System | 2019-02-05 Blood Glucose Meter Kit |
| 00852668007071 - BLE Smart® Blood Glucose Meter | 2019-02-05 Blood Glucose Meter Label |
| 00852668007095 - MyGlucoHealth® BT Meter | 2019-02-05Blood Glucose meter (label) |
| 00852668007095 - MyGlucoHealth® BT Meter | 2019-02-05 Blood Glucose meter (label) |
Trademark Results [MyGlucoHealth]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MYGLUCOHEALTH 79050869 3616194 Live/Registered |
Entra Health Systems LLC 2008-02-19 |
 MYGLUCOHEALTH 77664172 3908549 Live/Registered |
Entra Health Systems LLC 2009-02-05 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.