ENLIGHT BELT - S - RIGHT

GUDID 07898959841910

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
Primary Device ID07898959841910
NIH Device Record Key9f92de1e-5165-4a8c-8ba3-30d5bc43a964
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT BELT - S - RIGHT
Version Model NumberACE-0001G-0
Company DUNS897939320
Company NameTimpel S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107898959841910 [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 Date2023-09-11
Device Publish Date2023-09-01

On-Brand Devices [ENLIGHT BELT - S - RIGHT]

07898959841668The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
07898966433184The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
07898959841910The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom

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