On Call Diabetes Management Software

GUDID 00682607001118

PC Software

ACON LABORATORIES, INC.

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

• Primary Device ID: 00682607001118
• NIH Device Record Key: 95e056e9-5afd-46e2-a5b8-0abd7e389d46
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: On Call Diabetes Management Software
• Version Model Number: 1.2.89
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00682607001118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131469

FDA Product Code

• JQP: CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE

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: 2017-01-13

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