ENLIGHT BELT - XXS - LEFT

GUDID 07898959841880

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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.

Timpel S/A

Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical bioimpedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable Thoracic electrical impedance electrode array, reusable
Primary Device ID07898959841880
NIH Device Record Keyb43e0713-8b89-40f0-b88e-c5ba01863f47
Commercial Distribution StatusIn Commercial Distribution
Brand NameENLIGHT BELT - XXS - LEFT
Version Model NumberACE-0001D-0
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 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
GS107898959841880 [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 Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by Timpel S/A

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07898959841002 - ENLIGHT BELT - 5S - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841873 - ENLIGHT BELT - XXS - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841880 - ENLIGHT BELT - XXS - LEFT2023-09-11The 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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
07898959841880 - ENLIGHT BELT - XXS - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841897 - ENLIGHT BELT - XS - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841903 - ENLIGHT BELT - XS - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841910 - ENLIGHT BELT - S - RIGHT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
07898959841927 - ENLIGHT BELT - S - LEFT2023-09-11 The electrode belt is used to apply and acquire patient’s electrical impedance signals. Biocompatible, non-invasive and latex-
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