Duns Number:351157594
Device Description: The Coala Heart Monitor is a medical device system that can be used by healthcareprofessio The Coala Heart Monitor is a medical device system that can be used by healthcareprofessionals for electrocardiogram (ECG) and digital auscultation (stethoscope) recordings.Persons with known or suspected heart conditions can use the Coala Heart Monitor to recordECG and heart sounds simultaneously for detection of normal sinus rhythm (NSR) and atrialfibrillation (AF) and to make these recordings available to their physician.
Catalog Number
N/A
Brand Name
Coala Heart Monitor US Rx
Version/Model Number
201
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182040,K182040,K182040
Product Code
DXH
Product Code Name
Transmitters And Receivers, Electrocardiograph, Telephone
Public Device Record Key
c5f59a31-3829-4e36-a508-2a58cc441e86
Public Version Date
March 10, 2021
Public Version Number
2
DI Record Publish Date
July 11, 2019
Package DI Number
27350002700123
Quantity per Package
12
Contains DI Package
07350002700105
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
12 pack box