BLE Smart® Control Solution

GUDID 00852668007187

Control Solution Box 3 Pack

ENTRA HEALTH SYSTEMS LLC

Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control Glucose IVD, control

• Primary Device ID: 00852668007187
• NIH Device Record Key: 772d31e6-9598-44cc-a24e-900a2c714ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLE Smart® Control Solution
• Version Model Number: BLE-CS3
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 46 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852668007187 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160365

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-22
• Device Publish Date: 2018-11-20

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: 2019-02-22Control Solution Box 3 Pack
• 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)