ENLIGHT BELT - S - LEFT

GUDID 07898959841927

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 Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable

• Primary Device ID: 07898959841927
• NIH Device Record Key: 83685ac4-1d5c-4ffb-ae18-ba886840d3e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT BELT - S - LEFT
• Version Model Number: ACE-0001H-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	07898959841927 [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 - LEFT]

• 07898959841675: The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
• 07898959841927: The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom