Coala Heart Monitor US Rx

Basic Information

• Brand Name: Coala Heart Monitor US Rx
• Primary DI: 07350002700105
• Version / Model: 201
• Catalog Number: N/A
• Company Name: Coala-Life AB
• Labeler DUNS: 351157594
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-11
• Public Version: 2
• Public Version Date: 2021-03-10
• Public Version Status: Update
• Public Device Record Key: c5f59a31-3829-4e36-a508-2a58cc441e86

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	870.2920	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13017	Phonocardiograph	A device for recording heart sounds at the body surface through the heart's actions which cause vibrations that are transmitted through organs and tissue to the body surface. These are detected by microphones, processed in an electroacoustic transducer, and give sound characteristics in a phonocardiogram. This is used to assess the low frequency sounds (atrial and ventricular gallops), and high frequency sounds (mitral regurgitation and ventricular septal defect). Some also record subsonic frequencies (a few Hertz) considered as vibrations, typically recorded by an apexcardiograph. This method may also be integrated in other electrocardiograph (ECG) devices.	No	Active
62641	Electrocardiograph, home-use	A device intended to be used by a layperson in the home to acquire and process the electrical activity of the heart for digital display in the form of a graph, to assist a physician in assessing electrical cardiac physiology [electrocardiography (ECG)]. It may be available with a variety of features [e.g., single-channel, multichannel, interpretive software, data telemetry]; electrodes may be included.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	27350002700123	GS1	12 pack box	12	In Commercial Distribution
Primary	07350002700105	GS1
Package	17350002700119	GS1	Single pack box	1	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K182040	000