FDA.reportPublic FDA data

ENLIGHT BELT - 4S - LEFT

Primary DI
07898966433016
Brand
ENLIGHT BELT - 4S - LEFT
Company
Timpel S/A
Model
ACE-0001V-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
07898966433016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898966433016078989664330167898966433016

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
07908715700464ADHESIVE BELT SACE-ADH0A1P02026-07-24
07908715700518ADHESIVE BELT XSACE-ADH0A0P02026-07-24
07908715700525ADHESIVE BELT MACE-ADH0A2P02026-07-24
07908715700532ADHESIVE BELT LACE-ADH0A3P02026-07-24
07908715700549ADHESIVE BELT XLACE-ADH0A4P02026-07-24
07908715700976ADHESIVE BELT P0ACE-ADH0P0P02026-07-24
07908715700983ADHESIVE BELT P1ACE-ADH0P1P02026-07-24
07908715700990ADHESIVE BELT P2ACE-ADH0P2P02026-07-24
07908715701003ADHESIVE BELT P3ACE-ADH0P3P02026-07-24
07908715701010ADHESIVE BELT P4ACE-ADH0P4P02026-07-24
07908715701027ADHESIVE BELT XXSACE-ADH0P5P02026-07-24
07908715701492SENSOR BELT XSACE-BFH0A0P02026-07-24
07908715701522SENSOR BELT SACE-BFH0A1P02026-07-24
07908715701553SENSOR BELT MACE-BFH0A2P02026-07-24
07908715701584SENSOR BELT LACE-BFH0A3P02026-07-24
07908715701614SENSOR BELT XLACE-BFH0A4P02026-07-24
07908715701706PULMOMAPTPL-EH003-02026-07-18
07898966433306SHAPER No.2ACE-000352021-05-10
07898959841262SHAPER No.1AD-050012019-10-28
07898959841279SHAPER No.2AD-050022019-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908715700464ADHESIVE BELT STimpel S/AQEB2026-07-24
07908715700518ADHESIVE BELT XSTimpel S/AQEB2026-07-24
07908715700525ADHESIVE BELT MTimpel S/AQEB2026-07-24
07908715700532ADHESIVE BELT LTimpel S/AQEB2026-07-24
07908715700549ADHESIVE BELT XLTimpel S/AQEB2026-07-24
07908715700976ADHESIVE BELT P0Timpel S/AQEB2026-07-24
07908715700983ADHESIVE BELT P1Timpel S/AQEB2026-07-24
07908715700990ADHESIVE BELT P2Timpel S/AQEB2026-07-24
07908715701003ADHESIVE BELT P3Timpel S/AQEB2026-07-24
07908715701010ADHESIVE BELT P4Timpel S/AQEB2026-07-24
07908715701027ADHESIVE BELT XXSTimpel S/AQEB2026-07-24
07908715701492SENSOR BELT XSTimpel S/AQEB2026-07-24
07908715701522SENSOR BELT STimpel S/AQEB2026-07-24
07908715701553SENSOR BELT MTimpel S/AQEB2026-07-24
07908715701584SENSOR BELT LTimpel S/AQEB2026-07-24
07908715701614SENSOR BELT XLTimpel S/AQEB2026-07-24
07908715701706PULMOMAPTimpel S/AQEB2026-07-18
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