Coala Heart Monitor US Rx N/A

GUDID 27350002700123

The Coala Heart Monitor is a medical device system that can be used by healthcare professionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings. Persons with known or suspected heart conditions can use the Coala Heart Monitor to record ECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrial fibrillation (AF) and to make these recordings available to their physician.

Coala-Life AB

Phonocardiograph

• Primary Device ID: 27350002700123
• NIH Device Record Key: c5f59a31-3829-4e36-a508-2a58cc441e86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coala Heart Monitor US Rx
• Version Model Number: 201
• Catalog Number: N/A
• Company DUNS: 351157594
• Company Name: Coala-Life AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com
• Phone: 9496366530
• Email: carma.connely@coalalife.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350002700105 [Primary]
GS1	17350002700119 [Package]; Contains: 07350002700105; Package: Single pack box [1 Units]; In Commercial Distribution
GS1	27350002700123 [Package]; Contains: 07350002700105; Package: 12 pack box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182040

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-19
• Device Publish Date: 2019-07-11