King of Hearts AF

GUDID 00850725007071

King of Hearts Express AF Cardiac Event Recorder

Lifewatch

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 00850725007071
• NIH Device Record Key: f93f7839-22d4-4127-a89b-4031e7a9189a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: King of Hearts AF
• Version Model Number: King of Hearts AF
• Company DUNS: 797936734
• Company Name: Lifewatch
• 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: true
• 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: 1-800-700-3788
• Email: DL-CCCSupervisors@lifewatch.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850725007071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111745

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2016-09-16

Devices Manufactured by Lifewatch

• 00850725007002 - LifeWatch Mobile Cardiac Telemetry 3-Lead: 2019-05-07 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Ozone/Windows/Verizon)
• 00850725007019 - LifeWatch Mobile Cardiac Telemetry 3-Lead: 2019-05-07 3 Lead Continuous ECG Monitor & Arrhythmia Detector (ES400/Windows/Verizon)
• 00850725007026 - LifeWatch Mobile Cardiac Telemetry 3-Lead: 2019-05-07 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Brigadier/Android/Verizon)
• 00850725007033 - LifeWatch Mobile Cardiac Telemetry 3-Lead: 2019-05-07 3 Lead Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
• 00850725007040 - LifeWatch Mobile Cardiac Telemetry 1 Lead Patch: 2019-05-07 ECG Mini System Continuous ECG Monitor & Arrhythmia Detector (Universal Gateway/Android/Verizon)
• 00850725007057 - MicroER: 2019-05-07 Personal Electrocardiogram (ECG) Transmitter
• 00850725007064 - Explorer: 2019-05-07 Card Guard Personal Electrocardiogram Transmitter
• 00850725007071 - King of Hearts AF: 2019-05-07King of Hearts Express AF Cardiac Event Recorder
• 00850725007071 - King of Hearts AF: 2019-05-07 King of Hearts Express AF Cardiac Event Recorder