AccessGUDID - DEVICE: Continuous ECG Platform (00860008259233)

GUDID

Device Identifier (DI) Information

Brand Name: Continuous ECG Platform
Version or Model: VV350
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VIVALNK, INC.

Primary DI Number: 00860008259233
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 013311479 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
31733	Electrocardiography telemetric monitoring system	An assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 50 and 122 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between 50 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18cf745f-5d40-4623-ae83-949aa0e264b7
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022