ENLIGHT BELT - L – RIGHT

GUDID 07898959841705

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
Primary Device ID07898959841705
NIH Device Record Key80c465a4-98ed-4b20-9425-e3b3e7febe9a
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT BELT - L – RIGHT
Version Model NumberAD-04021
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

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
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107898959841705 [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 – RIGHT]

07898959841705The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom
07898966433221The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocom

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