ENLIGHT BELT - S - RIGHT

GUDID 07898959841910

The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.

Timpel S/A

Thoracic electrical bioimpedance electrode array, reusable

• Primary Device ID: 07898959841910
• NIH Device Record Key: 9f92de1e-5165-4a8c-8ba3-30d5bc43a964
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT BELT - S - RIGHT
• Version Model Number: ACE-0001G-0
• Company DUNS: 897939320
• Company Name: Timpel S/A
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07898959841910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211135

FDA Product Code

• QEB: Ventilatory Electrical Impedance Tomograph

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [ENLIGHT BELT - S - RIGHT]

• 07898959841668: The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
• 07898966433184: The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
• 07898959841910: The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom