ZENSOR

GUDID 15060484630003

The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated portable system connected to an electrode

INTELESENS LIMITED

Electrocardiography telemetric monitoring system

• Primary Device ID: 15060484630003
• NIH Device Record Key: d4dfacb2-7027-401c-bf5c-996680a0c7c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENSOR
• Version Model Number: PN0620
• Company DUNS: 231959888
• Company Name: INTELESENS LIMITED
• 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: false
• 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	05060484630006 [Primary]
GS1	15060484630003 [Package]; Contains: 05060484630006; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151027

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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-14

On-Brand Devices [ZENSOR]

• 15060484630089: The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable batt
• 15060484630003: The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable batt