On Call Express Mobile Blood Glucose Monitoring System 755012

GUDID 00682607001200

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

ACON LABORATORIES, INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 00682607001200
• NIH Device Record Key: 44f371aa-a704-4005-83b7-14eebd6ac3c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Express Mobile Blood Glucose Monitoring System
• Version Model Number: G115-10S
• Catalog Number: 755012
• 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

Operating and Storage Conditions

• 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	00682607001200 [Direct Marking]
GS1	00682607550128 [Primary]
GS1	00682607550142 [Primary]
GS1	10682607550125 [Package]; Contains: 00682607550128; Package: Case [4 Units]; In Commercial Distribution
GS1	10682607550149 [Package]; Contains: 00682607550142; Package: Case [4 Units]; In Commercial Distribution
GS1	20682607550122 [Package]; Contains: 10682607550125; Package: Carton [6 Units]; In Commercial Distribution
GS1	20682607550146 [Package]; Contains: 10682607550149; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180196

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-11
• Device Publish Date: 2019-06-14

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