VistaHub-WiFi 8001-01

GUDID 00850490007177

VistaHub-WiFi relay device to be used with the Vista Solution and VitalPatch biosensor.

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007177
• NIH Device Record Key: 76fbca64-93b4-4c20-92f8-f66d169e2d3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VistaHub-WiFi
• Version Model Number: 8001-01
• Catalog Number: 8001-01
• 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: true
• 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	00850490007177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152139

FDA Product Code

• MHX: Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

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

Devices Manufactured by Vital Connect, Inc.

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• 00850490007481 - VistaPhone: 2023-04-10 Vista Phone S9 relay device
• 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: 2020-11-10 Vista Solution 3 10-day Evaluation Kit