ENLIGHT ADDERE - P1

GUDID 07908715700877

Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.

Timpel S/A

Thoracic electrical impedance electrode array conductive skin adhesive tape

• Primary Device ID: 07908715700877
• NIH Device Record Key: f3eb1195-645f-4c8f-8024-5ae3bb467f02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENLIGHT ADDERE - P1
• Version Model Number: ACE-0000Q-0
• Company DUNS: 897939320
• Company Name: Timpel S/A
• Device Count: 2
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	07898959841392 [Primary]
GS1	07908715700877 [Unit of Use]

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: 2024-05-21
• Device Publish Date: 2024-05-13

Devices Manufactured by Timpel S/A

• 07908715700914 - ENLIGHT ADDERE - XXS: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700969 - ENLIGHT ADDERE - XL: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700860 - ENLIGHT ADDERE - P0: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700877 - ENLIGHT ADDERE - P1: 2024-05-21Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the patient’s body. Biocompatible, non- invasive and latex-free accessory in different sizes for adult and pediatric patients, designed for exclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
• 07908715700877 - ENLIGHT ADDERE - P1: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700884 - ENLIGHT ADDERE - P2: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700907 - ENLIGHT ADDERE - 4S: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 07908715700891 - ENLIGHT ADDERE - 5S: 2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
• 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