"VitalPatch™ Gentle Patch

GUDID 00850490007061

Vital Connect, Inc.

Electrocardiography telemetric monitoring system

• Primary Device ID: 00850490007061
• NIH Device Record Key: ccb307ae-b222-455a-a132-88952c0d7e94
• Commercial Distribution Discontinuation: 2017-04-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: "VitalPatch™ Gentle Patch
• Version Model Number: 3001-01
• 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: 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	00850490007054 [Primary]
GS1	00850490007061 [Package]; Contains: 00850490007054; Package: [5 Units]; Discontinued: 2017-04-30; Not in Commercial Distribution

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: 2016-08-23

Devices Manufactured by Vital Connect, Inc.

• 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