Vital-Trac

GUDID 00850070776028

PR Software OEM Embedded

Mindset Medical Inc.

Camera application software

• Primary Device ID: 00850070776028
• NIH Device Record Key: c30b2fa7-44fc-43c8-b5e6-1acaa0adbe59
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital-Trac
• Version Model Number: PROEMEMB
• Company DUNS: 119487830
• Company Name: Mindset Medical 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850070776028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241633

FDA Product Code

• QME: Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

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: 2025-06-02
• Device Publish Date: 2025-05-23