Rhythm Express

GUDID 00860000272414

The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a physician, typically 1 day to 4 weeks, and will continuously monitor ECG. RX-1 will function in one of three modes: a) Mobile Cardiac Telemetry (MCT), b) Event Recorder (ER), and Wireless Holter (WH). The device will connect to standard ECG electrodes to capture 2 channel ECGs. An embedded algorithm processes the acquired ECG to detect arrhythmias, compress the ECG, and remove most in-band noise without distorting ECG morphology. RX-1 incorporates a cellular modem to communicate with the RS-1 Web Service. The RX-1 device uses an embedded cellular modem on the Verizon LTE network. The RX-1 device is not a life-supporting or life-sustaining system. Clinical judgment and experience are used to check and interpret the data.

VIVAQUANT, INC.

Electrocardiography telemetric monitoring system transmitter

• Primary Device ID: 00860000272414
• NIH Device Record Key: 84428ca3-8da4-4df5-b8cf-fe18c387b39d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythm Express
• Version Model Number: RX-1
• Company DUNS: 832287945
• Company Name: VIVAQUANT, 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: 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	00860000272414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183704

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: 2
• Public Version Date: 2019-05-07
• Device Publish Date: 2019-03-18

On-Brand Devices [Rhythm Express]

• 00860000272414: The Rhythm Express RX-1 will be worn by adult patients for a period of time as prescribed by a p
• 00860000272407: The Rhythm Express RX-1 mini will be worn by adult patients for a period of time as prescribed b