BLE Smart® Blood Glucose System

GUDID 00852668007064

Blood Glucose Meter Kit

ENTRA HEALTH SYSTEMS LLC

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• Primary Device ID: 00852668007064
• NIH Device Record Key: 312048f2-0092-47d3-9a72-79eb69d26b44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLE Smart® Blood Glucose System
• Version Model Number: BLE-SMART-METER-FDA
• 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: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com
• Phone: 619-684-6232
• Email: support@entrahealth.com

Device Dimensions

• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 Microliter
• Total Volume: 0.5 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	00852668007064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160365

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

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• 00852668007019 - BLE Smart® Test Strips: 2019-02-05 Glucose Test Strips Unit of Use (each individual test strip)
• 00852668007064 - BLE Smart® Blood Glucose System: 2019-02-05Blood Glucose Meter Kit
• 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)