On Call Express II Glucose Monitoring System 757107

GUDID 00682607001675

Blood Glucose Meter, vial of 10 strips, 2mL bottle of Control 1, lancing device, 10 lancets (30G)

ACON LABORATORIES, INC.

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• Primary Device ID: 00682607001675
• NIH Device Record Key: fe23e44f-854c-464d-a33f-0b30d2253be5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express II Glucose Monitoring System
• Version Model Number: G117-10A
• Catalog Number: 757107
• 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
• 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
• 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.
• 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.
• 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	00682607571079 [Primary]
GS1	00682607571086 [Primary]
GS1	10682607571076 [Package]; Contains: 00682607571079; Package: Case [4 Units]; In Commercial Distribution
GS1	10682607571083 [Package]; Contains: 00682607571086; Package: Case [4 Units]; In Commercial Distribution
GS1	20682607571073 [Package]; Contains: 10682607571076; Package: Carton [6 Units]; In Commercial Distribution
GS1	20682607571080 [Package]; Contains: 10682607571083; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192175

FDA Product Code

• CGA: GLUCOSE OXIDASE, GLUCOSE
• 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: 2019-12-24
• Device Publish Date: 2019-12-16

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)