FDA.reportPublic FDA data

ENLIGHT BELT - S - LEFT

Primary DI
07898959841927
Brand
ENLIGHT BELT - S - LEFT
Company
Timpel S/A
Model
ACE-0001H-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
Rx
false
OTC
false
Sterile
false
Single use
false

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
K250464000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211135000Enlight 2100Timpel S.A.2022-01-06QEB
K250464000Enlight 2100 (TPL-E2103-0)Timpel S.A.2025-09-10QEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898959841927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898959841927078989598419277898959841927

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance 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.

Regulatory Flags#

DUNS number
897939320
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07898966433023ENLIGHT BELT - P0 - LEFTACE-0001X-02026-10-08
07898966433030ENLIGHT BELT - P0 - RIGHTACE-0001W-02026-10-08
07898966433047ENLIGHT BELT - P1 - LEFTACE-0001Z-02026-10-08
07898966433054ENLIGHT BELT - P1 - RIGHTACE-0001Y-02026-10-08
07898966433061ENLIGHT BELT - P1 - LEFTACE-00011-02026-10-08
07898966433078ENLIGHT BELT - P2 - RIGHTACE-00010-02026-10-08
07898959841163ENLIGHT ADDERE - XXSAD-03005-12024-05-13
07898959841217ENLIGHT ADDERE - XLAD-0300A-12024-05-13
07898959841477ENLIGHT ADDERE - 4SACE-0000E-02024-05-13
07898959841002ENLIGHT BELT - 5S - LEFTACE-0001T-02023-09-01
07898959841873ENLIGHT BELT - XXS - RIGHTACE-0001C-02023-09-01
07898959841880ENLIGHT BELT - XXS - LEFTACE-0001D-02023-09-01
07898959841897ENLIGHT BELT - XS - RIGHTACE-0001E-02023-09-01
07898959841903ENLIGHT BELT - XS - LEFTACE-0001F-02023-09-01
07898959841910ENLIGHT BELT - S - RIGHTACE-0001G-02023-09-01
07898959841934ENLIGHT BELT - M - RIGHTACE-0001J-02023-09-01
07898959841941ENLIGHT BELT - M - LEFTACE-0001L-02023-09-01
07898959841958ENLIGHT BELT - L - RIGHTACE-0001M-02023-09-01
07898959841965ENLIGHT BELT - L - LEFTACE-0001N-02023-09-01
07898959841972ENLIGHT BELT - XL - RIGHTACE-0001P-02023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
076401218817562ST200-100 LuMon™ MonitorSenTec AGQEB2026-10-23
07898966433023ENLIGHT BELT - P0 - LEFTTimpel S/AQEB2026-10-08
07898966433030ENLIGHT BELT - P0 - RIGHTTimpel S/AQEB2026-10-08
07898966433047ENLIGHT BELT - P1 - LEFTTimpel S/AQEB2026-10-08
07898966433054ENLIGHT BELT - P1 - RIGHTTimpel S/AQEB2026-10-08
07898966433061ENLIGHT BELT - P1 - LEFTTimpel S/AQEB2026-10-08
07898966433078ENLIGHT BELT - P2 - RIGHTTimpel S/AQEB2026-10-08
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