Explorer

GUDID 00850725007064

Card Guard Personal Electrocardiogram Transmitter

Lifewatch

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 00850725007064
• NIH Device Record Key: 59c70f7d-eb54-41b0-af73-e472ea826285
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Explorer
• Version Model Number: Explorer
• 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	00850725007064 [Primary]

FDA Product Code

• DXH: Transmitters And Receivers, Electrocardiograph, Telephone

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: 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: 2019-05-07Card Guard Personal Electrocardiogram Transmitter
• 00850725007064 - Explorer: 2019-05-07 Card Guard Personal Electrocardiogram Transmitter
• 00850725007071 - King of Hearts AF: 2019-05-07 King of Hearts Express AF Cardiac Event Recorder