On Call Express Glucose Control Solution Kit

GUDID 10682607557322

Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2

ACON LABORATORIES, INC.

Home-use/point-of-care blood glucose monitoring system IVD

• Primary Device ID: 10682607557322
• NIH Device Record Key: c439171a-8989-45a5-b83f-736ba41bcafc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express Glucose Control Solution Kit
• Version Model Number: G125-12D
• Company DUNS: 781100966
• Company Name: ACON LABORATORIES, INC.
• 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: false
• Manufacturing Date: false
• 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: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com
• Phone: +1(800)838-9502
• Email: support@aconlabs.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Keep out of direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607557325 [Primary]
GS1	10682607557322 [Package]; Contains: 00682607557325; Package: case [24 Units]; In Commercial Distribution
GS1	20682607557329 [Package]; Package: carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132086

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: 2018-07-06
• Device Publish Date: 2016-09-24

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