FDA.reportPublic FDA data

ENLIGHT ADDERE - P1

Primary DI
07898959841392
Brand
ENLIGHT ADDERE - P1
Company
Timpel S/A
Model
ACE-0000Q-0
Device description
Addere is a disposable accessory that envelopes the electrode belt andworks as the interface between the electrode belt and the patient’s body. Biocompatible, non-invasive and latex-free accessory in different sizes for adult and pediatric patients, designed forexclusive use with ENLIGHT Electrode Belts. Non-sterile and not to be sterilized.
Published
2024-05-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
07908715700365PackageGS15In Commercial Distribution
07898959841392PrimaryGS10
07908715700877Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908715700365079087157003657908715700365
07898959841392078989598413927898959841392
07908715700877079087157008777908715700877

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance electrode array conductive skin adhesive tapeA flat, flexible tape with an electrical conductive medium (gel) designed to be used during thoracic electrical impedance (bioimpedance) tomography (EIT) or segmentography to adhere an electrode array (typically belt-like) to the skin surface, and to function as a body-electrode interface to enable continuous bioimpedance measurements. This is a single-use device.

Regulatory Flags#

DUNS number
897939320
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
07898959841927ENLIGHT BELT - S - LEFTACE-0001H-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

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