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 ID07908715700877
NIH Device Record Keyf3eb1195-645f-4c8f-8024-5ae3bb467f02
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT ADDERE - P1
Version Model NumberACE-0000Q-0
Company DUNS897939320
Company NameTimpel S/A
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107898959841392 [Primary]
GS107908715700877 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEBVentilatory Electrical Impedance Tomograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-21
Device Publish Date2024-05-13

Devices Manufactured by Timpel S/A

07908715700914 - ENLIGHT ADDERE - XXS2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700969 - ENLIGHT ADDERE - XL2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700860 - ENLIGHT ADDERE - P02024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700877 - ENLIGHT ADDERE - P12024-05-21Addere 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 - P12024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700884 - ENLIGHT ADDERE - P22024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700907 - ENLIGHT ADDERE - 4S2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07908715700891 - ENLIGHT ADDERE - 5S2024-05-21 Addere is a disposable accessory that envelopes the electrode belt and works as the interface between the electrode belt and the
07898966433146 - ENLIGHT 21002024-01-03 ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cro

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