BLE Smart® Test Strips

GUDID 00850081003960

Glucose Test Strips

ENTRA HEALTH SYSTEMS LLC

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• Primary Device ID: 00850081003960
• NIH Device Record Key: 90497590-19cd-4b4f-bdb3-5fdd2d8e7f8a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLE Smart® Test Strips
• Version Model Number: BLE-TS50-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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

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

• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850081003960 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160365

FDA Product Code

• LFR: Glucose Dehydrogenase, Glucose

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-02-08
• Device Publish Date: 2017-01-27

On-Brand Devices [BLE Smart® Test Strips]

• 00852668007019: Glucose Test Strips Unit of Use (each individual test strip)
• 00850081003960: Glucose Test Strips