ENLIGHT 2100

GUDID 07898966433573

ENLIGHT 2100 is a non-invasive, radiation free medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as 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 and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 -134 cm.

Timpel S/A

Thoracic electrical bioimpedance system, tomographic
Primary Device ID07898966433573
NIH Device Record Keybc1fc903-92c4-484a-bdb4-e9bf7d0d1969
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT 2100
Version Model NumberTPL-E2103-1
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107898966433573 [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 Date2022-04-07
Device Publish Date2022-03-30

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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