ENLIGHT ELECTRODE ADDERE - SIZE M

GUDID 07898959841750

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 Electrode Belts. Non-sterile and not to be sterilized.

Timpel S/A

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Primary Device ID07898959841750
NIH Device Record Key8fa494ef-0dd9-4d8d-aeb4-0b9ea68b42e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT ELECTRODE ADDERE - SIZE M
Version Model NumberACE-00032
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
GS107898959841750 [Unit of Use]
GS107898966433276 [Primary]

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 Date2021-05-18
Device Publish Date2021-05-10

Devices Manufactured by Timpel S/A

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
07898959841002 - ENLIGHT BELT - 5S - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841873 - ENLIGHT BELT - XXS - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841880 - ENLIGHT BELT - XXS - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841897 - ENLIGHT BELT - XS - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841903 - ENLIGHT BELT - XS - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841910 - ENLIGHT BELT - S - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841927 - ENLIGHT BELT - S - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-

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