ENLIGHT 2100

GUDID 07898966433146

ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local impedance variation within a cross-section of a patient’s thorax. This information is presented to the clinician user as an adjunctive tool to other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78 -122 cm.

Timpel S/A

Thoracic electrical impedance system, tomographic
Primary Device ID07898966433146
NIH Device Record Key39e74d5c-8ea6-4371-9d53-674757b3bfb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT 2100
Version Model NumberTPL-E2103-0
Company DUNS897939320
Company NameTimpel S/A
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS107898966433146 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2024-01-03
Device Publish Date2021-04-20

On-Brand Devices [ENLIGHT 2100]

07898966433573ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from imp
07898966433146ENLIGHT 2100 is a non-invasive, non-radiation medical device that provides information of local

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