BLE Smart® Control Solution

GUDID 00852668007187

Control Solution Box 3 Pack

ENTRA HEALTH SYSTEMS LLC

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)