Vital Signs

GUDID 50607514500009

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate

OXEHEALTH LIMITED

Near-infrared camera vital sign measurement software

• Primary Device ID: 50607514500009
• NIH Device Record Key: 614c0f06-d4b3-4757-bf0c-97d205bc42ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs
• 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	50607514500009 [Primary]

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

Devices Manufactured by OXEHEALTH LIMITED

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