MY01 Mobile Application

GUDID 07540162030093

MY01 Inc

Compartmental-pressure monitoring system, single-use

• Primary Device ID: 07540162030093
• NIH Device Record Key: eb2efd20-e0d4-4793-be30-489122d5e849
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MY01 Mobile Application
• Version Model Number: v1.22
• Company DUNS: 203869834
• Company Name: MY01 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540162030093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242997

FDA Product Code

• LXC: Monitor, Pressure, Intracompartmental

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: 2025-05-07
• Device Publish Date: 2025-04-29

Devices Manufactured by MY01 Inc

• 07540162030093 - MY01 Mobile Application: 2025-05-07
• 07540162030093 - MY01 Mobile Application: 2025-05-07
• 07540162030017 - MY01 Continuous Compartmental Pressure Monitor: 2021-03-09