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 Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph Phonocardiograph
Primary Device ID27350002700123
NIH Device Record Keyc5f59a31-3829-4e36-a508-2a58cc441e86
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoala Heart Monitor US Rx
Version Model Number201
Catalog NumberN/A
Company DUNS351157594
Company NameCoala-Life AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com
Phone9496366530
Emailcarma.connely@coalalife.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107350002700105 [Primary]
GS117350002700119 [Package]
Contains: 07350002700105
Package: Single pack box [1 Units]
In Commercial Distribution
GS127350002700123 [Package]
Contains: 07350002700105
Package: 12 pack box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXHTransmitters And Receivers, Electrocardiograph, Telephone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-07-19
Device Publish Date2019-07-11
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