Oxevision Sleep system

GUDID 50607514500023

Sleep disorder interpretive software, professional-only

OXEHEALTH LIMITED

Sleep disorder interpretive software, professional-only

• Primary Device ID: 50607514500023
• NIH Device Record Key: 87cd947d-0210-4bbf-9e46-5df03d80ed8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxevision Sleep system
• Version Model Number: 2
• Company DUNS: 218519521
• Company Name: OXEHEALTH LIMITED
• 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: 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: false

Customer Support Contacts

• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com
• Phone: +1 (888) 871-8108
• Email: john.kemeny@oxehealth.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	50607514500023 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233618

FDA Product Code

• LEL: Device, Sleep Assessment

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: 2025-01-29
• Device Publish Date: 2025-01-21

Devices Manufactured by OXEHEALTH LIMITED

• 50607514500009 - Vital Signs: 2025-01-29 Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate
• 50607514500023 - Oxevision Sleep system: 2025-01-29Sleep disorder interpretive software, professional-only
• 50607514500023 - Oxevision Sleep system: 2025-01-29 Sleep disorder interpretive software, professional-only