FDA.reportPublic FDA data

ADHESIVE BELT P4

Primary DI
07908715701010
Brand
ADHESIVE BELT P4
Company
Timpel S/A
Model
ACE-ADH0P4P0
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
K250464000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908715701751PackageGS15In Commercial Distribution
07908715701010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908715701751079087157017517908715701751
07908715701010079087157010107908715701010

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
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
07898959841972ENLIGHT BELT - XL - RIGHTACE-0001P-02023-09-01
07898959841989ENLIGHT BELT - XL - LEFTACE-0001Q-02023-09-01
07898959841996ENLIGHT BELT - 5S - RIGHTACE-0001R-02023-09-01
07898966433009ENLIGHT BELT - 4S - RIGHTACE-0001U-02023-09-01
07898966433016ENLIGHT BELT - 4S - LEFTACE-0001V-02023-09-01
07898959841729ENLIGHT PATIENT REFERENCE CABLEDX-0TC032019-10-28

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
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
EIT11ST28510001ST285-100 LuMon™ Belt Size 116SenTec AGQEB2025-09-08