VitalPatch® RTM 4007-01

GUDID 00850490007450

VitalPatch Biosensor

Vital Connect, Inc.

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

• Primary Device ID: 00850490007450
• NIH Device Record Key: 7f5f0666-a852-443e-b523-a765a1d8d77a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VitalPatch® RTM
• Version Model Number: 4007-01
• Catalog Number: 4007-01
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	00850490007450 [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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• 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