VistaPhone

Basic Information

• Brand Name: VistaPhone
• Primary DI: 00850490007481
• Version / Model: 8303-03
• Catalog Number: 8303-03
• Company Name: Vital Connect, Inc.
• Labeler DUNS: 944642730
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-31
• Public Version: 1
• Public Version Date: 2023-04-10
• Public Version Status: New
• Public Device Record Key: 061e70e3-6fa5-4838-b283-d8f50055baf2

Device Description

Vista Phone S9 relay device

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: No
• Has Manufacturing Date: No
• 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
65828	Multiple vital physiological parameter monitoring system transceiver	An electrically-powered device intended to receive data relating to multiple vital physiological parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)] from an appropriate sensor, and wirelessly transmit the data to a parent device (e.g., monitor and/or an off-the-shelf computer/tablet) with appropriate software installed; it may in addition be intended to provide electrical energy to the connected probe/electrode.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850490007481	GS1

Premarket Submissions

Submission Number	Supplement Number
K193343	000