FDA.reportPublic FDA data

ENLIGHT BELT - 5S - RIGHT

Primary DI
07898959841996
Brand
ENLIGHT BELT - 5S - RIGHT
Company
Timpel S/A
Model
ACE-0001R-0
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 and pediatric patients, designed for exclusive use with ENLIGHT. Non-sterile and not to be sterilized. It must be used with Addere.
Published
2023-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QEBVentilatory Electrical Impedance Tomograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEBVentilatory Electrical Impedance TomographAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211135000Enlight 2100Timpel S.A.2022-01-06QEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898959841996PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898959841996078989598419967898959841996

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical bioimpedance electrode array, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
897939320
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898966433306SHAPER No.2ACE-000352021-05-10
07898959841262SHAPER No.1AD-050012019-10-28
07898959841279SHAPER No.2AD-050022019-10-28
07898959841163ENLIGHT ADDERE - XXSAD-03005-12024-05-13
07898959841217ENLIGHT ADDERE - XLAD-0300A-12024-05-13
07898959841385ENLIGHT ADDERE - P0ACE-0000P-02024-05-13
07898959841392ENLIGHT ADDERE - P1ACE-0000Q-02024-05-13
07898959841408ENLIGHT ADDERE - P2ACE-0000R-02024-05-13
07898959841477ENLIGHT ADDERE - 4SACE-0000E-02024-05-13
07898959841484ENLIGHT ADDERE - 5SACE-0000D-02024-05-13
07898959841170ENLIGHT ELECTRODE ADDERE- SIZE XSAD-030062019-10-28
07898959841187ENLIGHT ELECTRODE ADDERE- SIZE SAD-030072019-10-28
07898959841194ENLIGHT ELECTRODE ADDERE- SIZE MAD-030082019-10-28
07898959841200ENLIGHT ELECTRODE ADDERE- SIZE LAD-030092019-10-28
07908715700914ENLIGHT ADDERE - XXSAD-03005-12024-05-13
07908715700969ENLIGHT ADDERE - XLAD-0300A-12024-05-13
07908715700860ENLIGHT ADDERE - P0ACE-0000P-02024-05-13
07908715700877ENLIGHT ADDERE - P1ACE-0000Q-02024-05-13
07908715700884ENLIGHT ADDERE - P2ACE-0000R-02024-05-13
07908715700907ENLIGHT ADDERE - 4SACE-0000E-02024-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EIT12ST20010002ST200-100 LuMon™ Monitor SenTec AGQEB2025-09-08
07640121881053103583 LuMon™ Contact Gel KitSenTec AGQEB2025-09-08
EIT11ST12010001ST120-100 LuMon™ Connector 2.0 SenTec AGQEB2025-09-08
EIT11ST27210001ST272-100 LuMon™ Belt Size 19SenTec AGQEB2025-09-08
EIT11ST27310001ST273-100 LuMon™ Belt Size 22SenTec AGQEB2025-09-08
EIT11ST27410001ST274-100 LuMon™ Belt Size 26SenTec AGQEB2025-09-08
EIT11ST27510001ST275-100 LuMon™ Belt Size 30SenTec AGQEB2025-09-08
EIT11ST27610001ST276-100 LuMon™ Belt Size 35SenTec AGQEB2025-09-08
EIT11ST27710001ST277-100 LuMon™ Belt Size 40SenTec AGQEB2025-09-08
EIT11ST27810001ST278-100 LuMon™ Belt Size 47SenTec AGQEB2025-09-08
EIT11ST28210001ST282-100 LuMon™ Belt Size 80SenTec AGQEB2025-09-08
EIT11ST28310001ST283-100 LuMon™ Belt Size 92SenTec AGQEB2025-09-08
EIT11ST28410001ST284-100 LuMon™ Belt Size 104SenTec AGQEB2025-09-08
EIT11ST28510001ST285-100 LuMon™ Belt Size 116SenTec AGQEB2025-09-08
07898959841163ENLIGHT ADDERE - XXSTimpel S/AQEB2024-05-13
07898959841217ENLIGHT ADDERE - XLTimpel S/AQEB2024-05-13
07898959841385ENLIGHT ADDERE - P0Timpel S/AQEB2024-05-13
07898959841392ENLIGHT ADDERE - P1Timpel S/AQEB2024-05-13
07898959841408ENLIGHT ADDERE - P2Timpel S/AQEB2024-05-13
07898959841477ENLIGHT ADDERE - 4STimpel S/AQEB2024-05-13
07898959841484ENLIGHT ADDERE - 5STimpel S/AQEB2024-05-13
07908715700914ENLIGHT ADDERE - XXSTimpel S/AQEB2024-05-13
07908715700969ENLIGHT ADDERE - XLTimpel S/AQEB2024-05-13
07908715700860ENLIGHT ADDERE - P0Timpel S/AQEB2024-05-13
07908715700877ENLIGHT ADDERE - P1Timpel S/AQEB2024-05-13
07908715700884ENLIGHT ADDERE - P2Timpel S/AQEB2024-05-13
07908715700907ENLIGHT ADDERE - 4STimpel S/AQEB2024-05-13
07908715700891ENLIGHT ADDERE - 5STimpel S/AQEB2024-05-13
07898959841002ENLIGHT BELT - 5S - LEFTTimpel S/AQEB2023-09-01
07898959841873ENLIGHT BELT - XXS - RIGHTTimpel S/AQEB2023-09-01