HeartCheck CardiBeat HC-WC-01

GUDID 00812324000044

HeartCheck CardiBeat portable ECG monitor

CardioComm Solutions, Inc

Electrocardiographic monitor

• Primary Device ID: 00812324000044
• NIH Device Record Key: 18162933-d85a-4567-960f-00dfd32d36bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HeartCheck CardiBeat
• Version Model Number: HC-WC-01
• Catalog Number: HC-WC-01
• Company DUNS: 251043907
• Company Name: CardioComm Solutions, Inc
• 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: false
• Lot Batch: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812324000044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181310

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: 2019-03-12
• Device Publish Date: 2019-03-04

Devices Manufactured by CardioComm Solutions, Inc

• 00812324000204 - GEMS Win Arrhythmia: 2023-11-17 Global ECG Management System (GEMS) for Windows Arrhythmia
• 00812324000211 - GEMS Win TTM: 2023-11-17 Global ECG Management System for Windows with Arrhythmia and TTM
• 00812324000242 - GEMS Win AutoAttendant: 2023-11-17 GEMS Win AutoAttendant
• 00812324000259 - GEMS Win Air: 2023-11-17 GEMS Win Air
• 00812324000228 - GEMS Win TTM & ICD: 2023-11-16 GEMS Win ARR TTM & Full Pacing
• 00812324000266 - GEMS Win HL7: 2023-11-16 HL7 plug-in module for GEMS Win
• 00812324000044 - HeartCheck CardiBeat: 2019-03-12HeartCheck CardiBeat portable ECG monitor
• 00812324000044 - HeartCheck CardiBeat: 2019-03-12 HeartCheck CardiBeat portable ECG monitor
• 00812324000020 - HeartCheck BT PEN Handheld ECG: 2018-07-06 Bluetooth PEN Handheld ECG