VistaTablet™ 2.0 (Boxed) 8102-01

GUDID 00850490007306

VistaTablet™ 2.0 (Boxed)

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007306
• NIH Device Record Key: 0d1b8d52-f3f6-409c-b99f-856da02c83f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaTablet™ 2.0 (Boxed)
• Version Model Number: 8102-01
• Catalog Number: 8102-01
• 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: false
• Serial Number: true
• 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	00850490007306 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-02
• Device Publish Date: 2019-07-25

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• 00850490007412 - Vista Solution 3 10-day Evaluation Kit: 2020-11-10 Vista Solution 3 10-day Evaluation Kit