FDA.reportPublic FDA data

ENLIGHT 1810

Primary DI
07898959841415
Brand
ENLIGHT 1810
Company
Timpel S/A
Model
TP-ENU00-0
Device description
"""ENLIGHT 1810 is a non-invasive and non-radiation medical device that provides information from impedance variation from a cross-section of a patient’s thorax. This information is presented to the clinician user as adjunctive tool to be used with other clinical information to assess the patient’s ventilation.It is intended for mechanically ventilated adult patients in a hospital setting, whose thorax perimeter is within the range of 78-122 cm.ENLIGHT1810 and its accessories are prescription use only."""
Published
2019-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
07898959841415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898959841415078989598414157898959841415

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical bioimpedance system, tomographicAn assembly of devices designed to perform continuous bioimpedance measurements throughout a cross-section of the thorax, to provide real-time feedback of lung function during controlled, assisted or spontaneous ventilation. It typically consists of a mobile trolley, a mains electricity (AC-powered) unit with a monitor and controls, connecting cables, and an electrode chest belt (typically with 16-32 electrodes). The technique [electrical impedance tomography (EIT)] uses single-frequency, low-amplitude alternating current applied by a pair of electrodes whereby the generated electrical potentials at the body surface are continuously measured by other electrodes.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+551130880305qualidade@timpelmedical.com

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