Commwell

Basic Information

• Brand Name: Commwell
• Primary DI: 07290012672057
• Version / Model: RPCS5000
• Catalog Number: 5-001-00
• Company Name: COMMWELL RESEARCH & DEVELOPMENT LTD.
• Labeler DUNS: 532013976
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-26
• Public Version: 6
• Public Version Date: 2021-11-10
• Public Version Status: Update
• Public Device Record Key: 2c52e5e0-0389-457b-9f75-b678107ef099

Device Description

An instrument designed to measure electrical potentials on the body surface to generate a record of the electrical currents associated with heart muscle activity [i.e., an electrocardiogram (ECG)] for the assessment of cardiac physiology. It records electrical signals from 12 leads simultaneously, thus simplifying and facilitating the interpretation of the record by enabling the comparison of 12-lead recording of the same heartbeat. It records data in electronic or printed form for Bluetooth transmission to a mobile device for later Wi-Fi or GSM transmission to a predefined web server for analysis by software or by a healthcare professional.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
33586	General-purpose multi-parameter bedside monitor	An electrically-powered device/device assembly designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically set-up by the patient bedside and often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use and is not intended to be worn on the body.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290012672057	GS1

Premarket Submissions

Submission Number	Supplement Number
K010791	000