VistaPoint Software User Interface 6100-03

GUDID 00850490007382

User interface in the patient's room

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007382
• NIH Device Record Key: 12837249-5718-4c26-a7f1-c2635337e9ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaPoint Software User Interface
• Version Model Number: 6100-03
• Catalog Number: 6100-03
• 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: 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	00850490007382 [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: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [VistaPoint Software User Interface]

• 00850490007160: User interface in the patient's room
• 00850490007382: User interface in the patient's room