GEMS Win Arrhythmia GW-ARR

GUDID 00812324000204

Global ECG Management System (GEMS) for Windows Arrhythmia

CardioComm Solutions, Inc

Cardiac mapping system computer

• Primary Device ID: 00812324000204
• NIH Device Record Key: 2c633c41-f60e-4b59-ac2e-498ef30dab87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GEMS Win Arrhythmia
• Version Model Number: GW-ARR
• Catalog Number: GW-ARR
• Company DUNS: 251043907
• Company Name: CardioComm Solutions, Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812324000204 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022297

FDA Product Code

• DSH: Recorder, Magnetic Tape, Medical

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: 2023-11-17
• Device Publish Date: 2023-11-09

Devices Manufactured by CardioComm Solutions, Inc

• 00812324000204 - GEMS Win Arrhythmia: 2023-11-17Global ECG Management System (GEMS) for Windows Arrhythmia
• 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: 2019-03-12 HeartCheck CardiBeat portable ECG monitor
• 00812324000020 - HeartCheck BT PEN Handheld ECG: 2018-07-06 Bluetooth PEN Handheld ECG