VistaPoint Software User Interface 6100-01

GUDID 00850490007160

User interface in the patient's room

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007160
• NIH Device Record Key: afa67308-dcd0-4ca2-b68a-e3252b995aa7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaPoint Software User Interface
• Version Model Number: 6100-01
• Catalog Number: 6100-01
• 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	00850490007160 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170973

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-20

On-Brand Devices [VistaPoint Software User Interface]

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