Holter Kit (Wi-Fi Only) 2400-01

GUDID 00850490007511

Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal Pads

Vital Connect, Inc.

Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder Telemetric electrocardiographic ambulatory recorder

• Primary Device ID: 00850490007511
• NIH Device Record Key: af0c09ff-998b-4a7b-beff-ac977e0fcffd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Holter Kit (Wi-Fi Only)
• Version Model Number: 2400-01
• Catalog Number: 2400-01
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• 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	00850490007511 [Primary]

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: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by Vital Connect, Inc.

• 00850490007511 - Holter Kit (Wi-Fi Only): 2023-09-08Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal Pads
• 00850490007511 - Holter Kit (Wi-Fi Only): 2023-09-08 Contains VistaPhone (Wi-Fi Only) with protective case, charger, charge cable, Adhesive Overlay, Alcohol Wipes, Adhesive Removal
• 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