AccessGUDID - DEVICE: ENLIGHT BELT - M

GUDID

Device Identifier (DI) Information

Brand Name: ENLIGHT BELT - M – RIGHT
Version or Model: ACE-00026
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Timpel S/A

Primary DI Number: 07898966433207
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 897939320 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61679	Thoracic electrical impedance electrode array, single-use	A noninvasive configuration of multiple electrodes (e.g., patches, belt-like) intended to be affixed to the thorax to perform continuous bioimpedance measurements for assessment of lung function (e.g., respiratory rate) or pulmonary conditions (e.g., atelectasis, pneumothorax, endotracheal tube misplacement) of a ventilated or spontaneous breathing patient; it is intended to be used in conjunction with a parent device [e.g., monitor, thoracic electrical impedance tomography (EIT) or segmentography system]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QEB	Ventilatory Electrical Impedance Tomograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN170072	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7681ae1d-2e72-4c09-abd8-9608ba475d0d
Public Version Date: January 03, 2024
Public Version Number: 3
DI Record Publish Date: May 10, 2021