ZENSOR

GUDID 15060484630089

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: 15060484630089
• NIH Device Record Key: 08560d5b-b5c1-4e89-8763-2ccf0f21dbf1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZENSOR
• Version Model Number: PN1287
• 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	05060484630082 [Primary]
GS1	15060484630089 [Package]; Contains: 05060484630082; 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: 1
• Public Version Date: 2019-02-07
• Device Publish Date: 2019-01-07

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