On Call Express II Glucose Monitoring System 757114

GUDID 20682607571141

Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G)

ACON LABORATORIES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 20682607571141
• NIH Device Record Key: 538af0e9-d16f-4ed2-aa67-8520c4d5d40c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express II Glucose Monitoring System
• Version Model Number: G117-10A
• Catalog Number: 757114
• 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: true
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607001675 [Direct Marking]
GS1	00682607571147 [Primary]
GS1	20682607571141 [Package]; Contains: 00682607571147; Package: Carton [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192175

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-23
• Device Publish Date: 2020-09-15

On-Brand Devices [On Call Express II Glucose Monitoring System]

• 00682607001675: Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G
• 20682607571141: Blood Glucose Meter, 100 test strips, 2mL bottle of Control 1, lancing device, 100 lancets (30G)