FDA.reportPublic FDA data

ENLIGHT 2100

Primary DI
07898966433573
Brand
ENLIGHT 2100
Company
Timpel S/A
Model
TPL-E2103-1
Device description
ENLIGHT 2100 is a non-invasive, radiation free 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 other clinical information in order to support the user’s assessment of variations in regional air content within a cross section of a patient’s lungs. It is intended for mechanically ventilated adult and pediatric patients in a hospital setting, whose thorax perimeter is within the range of 37.5 -134 cm.
Published
2022-03-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

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
07898966433573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898966433573078989664335737898966433573

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance 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, an electrically-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.

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
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