VistaCenter

Basic Information

• Brand Name: VistaCenter
• Primary DI: 00850490007375
• Version / Model: 6200-03
• Catalog Number: 6200-03
• Company Name: Vital Connect, Inc.
• Labeler DUNS: 944642730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-11-02
• Public Version: 1
• Public Version Date: 2020-11-10
• Public Version Status: New
• Public Device Record Key: 407cc2ae-5946-40a2-ab5f-c469a59caf4f

Device Description

Multipatient user interface, convenience view of VistaPoint

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: No
• Has Lot/Batch Number: Yes
• 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
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	870.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850490007375	GS1

Premarket Submissions

Submission Number	Supplement Number
K193343	000