Vista Solution 3 10-day Evaluation Kit 9610

GUDID 00850490007412

Vista Solution 3 10-day Evaluation Kit

Vital Connect, Inc.

Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007412
• NIH Device Record Key: 8ae124b6-29c9-45a6-ba47-7cea4fb6e728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vista Solution 3 10-day Evaluation Kit
• Version Model Number: 9610
• Catalog Number: 9610
• Company DUNS: 944642730
• Company Name: Vital Connect, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	00850490007412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192757

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

Devices Manufactured by Vital Connect, Inc.

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• 00850490007504 - VistaPhone Compact Cardiac Monitoring Kit: 2023-04-10 Compact Cardiac Monitoring Kit
• 00850490007467 - VistaPhone: 2021-01-25 Vista Phone A21 relay device
• 00850490007375 - VistaCenter: 2020-11-10 Multipatient user interface, convenience view of VistaPoint
• 00850490007382 - VistaPoint Software User Interface: 2020-11-10 User interface in the patient's room
• 00850490007399 - VistaTablet: 2020-11-10 Vista Tablet relay device
• 00850490007412 - Vista Solution 3 10-day Evaluation Kit: 2020-11-10Vista Solution 3 10-day Evaluation Kit
• 00850490007412 - Vista Solution 3 10-day Evaluation Kit: 2020-11-10 Vista Solution 3 10-day Evaluation Kit