HeartCheck CardiBeat

Basic Information

• Brand Name: HeartCheck CardiBeat
• Primary DI: 00812324000044
• Version / Model: HC-WC-01
• Catalog Number: HC-WC-01
• Company Name: CardioComm Solutions, Inc
• Labeler DUNS: 251043907
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-04
• Public Version: 1
• Public Version Date: 2019-03-12
• Public Version Status: New
• Public Device Record Key: 18162933-d85a-4567-960f-00dfd32d36bd

Device Description

HeartCheck CardiBeat portable ECG monitor

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
35195	Electrocardiographic monitor	A mains electricity (AC-powered) bedside device designed to continuously detect, measure, and display a patient's electrocardiogram (ECG) through leads and sensors attached to the patient; it also typically displays heart rate. The device is typically equipped with audible and/or visual alarms that are triggered when the patient's parameters drop below or exceed pre-set limits.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812324000044	GS1

Premarket Submissions

Submission Number	Supplement Number
K181310	000