MyGlucoHealth® BT Meter Kit

GUDID 00850081003007

Blood Glucose Meter Kit

ENTRA HEALTH SYSTEMS LLC

Glucose monitoring system IVD, home-use

• Primary Device ID: 00850081003007
• NIH Device Record Key: 8d814c15-8bb5-439e-8dae-d373c728b99c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MyGlucoHealth® BT Meter Kit
• 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: true
• 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: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: support@entrahealth.com
• Phone: 6196846232
• Email: 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	00850081003007 [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: 4
• Public Version Date: 2018-11-06
• 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: 2019-02-05 Blood Glucose meter (label)