FDA.reportPublic FDA data

SENSOR BELT XL

Primary DI
07908715701614
Brand
SENSOR BELT XL
Company
Timpel S/A
Model
ACE-BFH0A4P0
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
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
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
07908715701614PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908715701614079087157016147908715701614

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical impedance electrode array, reusableA noninvasive configuration of multiple electrodes (e.g., patches, belt-like) intended to be affixed to the thorax to perform continuous bioimpedance measurements for assessment of lung function (e.g., respiratory rate) or pulmonary conditions (e.g., atelectasis, pneumothorax, endotracheal tube misplacement) of a ventilated or spontaneous breathing patient; it is intended to be used in conjunction with a parent device [e.g., monitor, thoracic electrical impedance tomography (EIT) or segmentography system]. This is a reusable 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
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
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
07908715701706PULMOMAPTPL-EH003-02026-07-18
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

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
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