Zensor electrode

GUDID 15060484630010

The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable, pre-gelled, self-adhesive, three lead electrode array,

INTELESENS LIMITED

Electrocardiographic electrode, single-use

• Primary Device ID: 15060484630010
• NIH Device Record Key: e10b998a-3ed5-4953-aac8-10b98751c6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zensor electrode
• Version Model Number: PN1088
• Company DUNS: 231959888
• Company Name: INTELESENS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060484630013 [Primary]
GS1	15060484630010 [Package]; Contains: 05060484630013; Package: [4 Units]; In Commercial Distribution

FDA Product Code

• MLN: Electrode, Electrocardiograph, Multi-Function

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: 2018-06-14
• Device Publish Date: 2018-05-14

On-Brand Devices [Zensor electrode]

• 05060484630099: The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable,
• 15060484630010: The zensor electrode array, electrocardiograph (ECG) and respiration electrode is a disposable,