FDA.reportPublic FDA data

ENLIGHT ELECTRODE ADDERE - SIZE M

Primary DI
07898966433276
Brand
ENLIGHT ELECTRODE ADDERE - SIZE M
Company
Timpel S/A
Model
ACE-00032
Device description
Addere is a disposable accessory that envelopes the electrode belt and works 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 for exclusive use with Electrode Belts. Non-sterile and not to be sterilized.
Published
2021-05-10
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
DEN170072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN170072000Enlight 1810Timpel, Inc.2018-12-20QEB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07898966433276PrimaryGS10
07898959841750Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898966433276078989664332767898966433276
07898959841750078989598417507898959841750

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
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