GLUCOFACTS® DELUXE 3515

GUDID 00301933515013

Diabetes Management Software

ASCENSIA DIABETES CARE US INC.

Self-care monitoring/reporting software

• Primary Device ID: 00301933515013
• NIH Device Record Key: bdd4e750-bd12-475b-b7ab-22b755ce086e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GLUCOFACTS® DELUXE
• Version Model Number: 3515
• Catalog Number: 3515
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18003488100
• Email: support@contournext.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301933515013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091820

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: 2016-09-16

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