Emay

GUDID 04897087200104

It's designed for family and individual users to track heart activity at home, at work or on a trip in case of cardiac situation that needs evaluation

EMAY (HK) LIMITED

Electrocardiographic monitor

• Primary Device ID: 04897087200104
• NIH Device Record Key: c7375f86-073c-4201-bb1f-b3f03e824cb9
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Emay
• Version Model Number: EMG-10
• Company DUNS: 664020405
• Company Name: EMAY (HK) 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: true
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	04897087200104 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152863

FDA Product Code

• DPS: Electrocardiograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-15

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
• 04897087200302: The Fingertip Pulse Oximeter is non-invasive device intended for spotchecking of functional oxy