EMAY

GUDID 04897087200098

The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate.

EMAY (HK) LIMITED

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• Primary Device ID: 04897087200098
• NIH Device Record Key: 194f6087-bacd-4076-8ff1-f035c7a4220c
• Commercial Distribution Discontinuation: 2030-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMAY
• Version Model Number: SleepO2 Pro
• Company DUNS: 664020405
• Company Name: EMAY (HK) LIMITED
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: true
• 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	04897087200098 [Primary]

FDA Product Code

• OCH: Oximeter, Infrared, Sporting, Aviation

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: 2024-01-26
• Device Publish Date: 2024-01-18

On-Brand Devices [EMAY]

• 04897087201019: Electronic Thermometer
• 04897087200104: It's designed for family and individual users to track heart activity at home, at work or on a t
• 04897087200012: Clinical basal thermometer, intended to measure human body temperature
• 04897087200203: It's designed for family and individual users to track heart activity at home, at work or on a t
• 04897087200807: The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxy
• 04897087200036: SleepO2
• 04897087206120: It's designed for family and individual users to track heart activity at home, at work or on a t
• 04897087200098: The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxy