ENLIGHT BELT – 5S – LEFT

GUDID 07898966433351

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. Disposable. Non-sterile and not to be sterilized. It must be used with Addere.

Timpel S/A

Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use

• Primary Device ID: 07898966433351
• NIH Device Record Key: 111abf2e-0660-4381-af90-57f2cbf04ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT BELT – 5S – LEFT
• Version Model Number: ACE-00041
• 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: true
• 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	07898966433351 [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: 2022-04-07
• Device Publish Date: 2022-03-30

Devices Manufactured by Timpel S/A

• 07898966433146 - ENLIGHT 2100: 2024-01-03 ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cro
• 07898959841002 - ENLIGHT BELT - 5S - LEFT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841873 - ENLIGHT BELT - XXS - RIGHT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841880 - ENLIGHT BELT - XXS - LEFT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841897 - ENLIGHT BELT - XS - RIGHT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841903 - ENLIGHT BELT - XS - LEFT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841910 - ENLIGHT BELT - S - RIGHT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
• 07898959841927 - ENLIGHT BELT - S - LEFT: 2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-