Continuous ECG Platform

GUDID 00865064000157

VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare professionals for record and display of physiological data within healthcare settings or at home. This includes electrocardiogram (ECG), accelerometer data, R-R Interval and heart rate. Data is transmitted wirelessly to a separate location (such as a mobile phone) for storage and display. The VV330 Continuous ECG Platform can be configured by Authorized Persons to modify or merge or ignore any of the operational alerts, but not to set new alerts related to physiological data. The device is not intended to be used on critical care patients and is intended to supplement vital signs recording for later viewing by healthcare professionals, not to replace current standards of care. The device is an ambulatory, continuous recording system intended for use on general care patients and on patients who are 18 years of age or older.

VIVALNK, INC.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00865064000157
• NIH Device Record Key: 7c4bb2f3-51d8-43b9-985b-11ad68106975
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Continuous ECG Platform
• Version Model Number: VV330
• Company DUNS: 013311479
• Company Name: VIVALNK, 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: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 113 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865064000157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191870

FDA Product Code

• DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency

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: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [Continuous ECG Platform]

• 00865064000157: VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare prof
• 00860008259233: VV330 Continuous ECG Platform is a wireless recording system intended for use by healthcare prof