Commwell 5-001-00

GUDID 07290012672057

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.

COMMWELL RESEARCH & DEVELOPMENT LTD.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 07290012672057
• NIH Device Record Key: 2c52e5e0-0389-457b-9f75-b678107ef099
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Commwell
• Version Model Number: RPCS5000
• Catalog Number: 5-001-00
• Company DUNS: 532013976
• Company Name: COMMWELL RESEARCH & DEVELOPMENT LTD.
• 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: true
• Manufacturing Date: true
• 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	07290012672057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010791

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2017-01-26

On-Brand Devices [Commwell]

• 07290012672064: ECG Mgmt Sys with ECG Analysis
• 07290012672057: An instrument designed to measure electrical potentials on the body surface to generate a record
• 07290012672026: An instrument designed to measure electrical potentials on the body surface to generate a record
• 07290012672019: An instrument designed to measure electrical potentials on the body surface to generate a record