ENLIGHT BELT – XS – RIGHT

GUDID 07898966433160

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 pediatric and neonatal patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized.

Timpel S/A

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Primary Device ID07898966433160
NIH Device Record Keydf96f96d-1239-4951-9967-cf8ca464d2e0
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT BELT – XS – RIGHT
Version Model NumberACE-00022
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 Usetrue
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
GS107898966433160 [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

On-Brand Devices [ENLIGHT BELT – XS – RIGHT]

07898959841644The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
07898966433160The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom

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