ENLIGHT BELT - L – LEFT

GUDID 07898959841712

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

Thoracic electrical bioimpedance system electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical bioimpedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use Thoracic electrical impedance electrode array, single-use
Primary Device ID07898959841712
NIH Device Record Key3a779293-247e-4af9-a4c5-20af7b96a12d
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT BELT - L – LEFT
Version Model NumberAD-04022
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

Customer Support Contacts

Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com
Phone+551130880305
Emailqualidade@timpelmedical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107898959841712 [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 Date2019-11-05
Device Publish Date2019-10-28

On-Brand Devices [ENLIGHT BELT - L – LEFT]

07898959841712The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
07898966433238The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom

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