VistaPhone 8303-03

GUDID 00850490007481

Vista Phone S9 relay device

Vital Connect, Inc.

Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver Multiple vital physiological parameter monitoring system transceiver

• Primary Device ID: 00850490007481
• NIH Device Record Key: 061e70e3-6fa5-4838-b283-d8f50055baf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaPhone
• Version Model Number: 8303-03
• Catalog Number: 8303-03
• Company DUNS: 944642730
• Company Name: Vital Connect, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	00850490007481 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193343

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: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [VistaPhone]

• 00850490007436: Vista Phone relay device
• 00850490007467: Vista Phone A21 relay device
• 00850490007481: Vista Phone S9 relay device