ARK Care® VITA Patient Mobile Application

GUDID 00015482000042

ARK Care VITA is a patient mobile application of the ARK Care Advance Diabetes Management System that is a solution for people with diabetes to upload and store their blood glucose readings from their blood glucose meters (BGMs). The system also allows healthcare providers to access their patients’ logbooks and BGM data, which could help increase the effectiveness of care and improve outcomes.

ARKRAY USA, INC.

Self-care monitoring/reporting software

• Primary Device ID: 00015482000042
• NIH Device Record Key: 9e9d41ca-a76e-4f7a-ae1a-6730eaafd7d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARK Care® VITA Patient Mobile Application
• Version Model Number: Ver 1.3.
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: false

Customer Support Contacts

• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com
• Phone: 1-855-646-3235
• Email: arkcareadvance@arkrayusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482000042 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-03-12

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