VistaTablet 8103-01

GUDID 00850490007399

Vista Tablet relay device

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007399
• NIH Device Record Key: 2a82f2e5-416d-4ef6-b00d-d9fba2cc8f2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaTablet
• Version Model Number: 8103-01
• Catalog Number: 8103-01
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00850490007399 [Primary]
GS1	00850490007405 [Package]; Package: [1 Units]; In Commercial Distribution

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: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [VistaTablet]

• 00850490007207: VistaTablet is a tablet which will be running the VistaPoint software user interface in a Web co
• 00850490007429: VistaTablet Relay Device
• 00850490007399: Vista Tablet relay device