FDA.reportPublic FDA data

SHAPER No.2

Primary DI
07898966433306
Brand
SHAPER No.2
Company
Timpel S/A
Model
ACE-00035
Device description
The shaper is a disposable accessory to assist the Electrode Belt to better fit the contour of the patient's chest, if needed. Available in two sizes, biocompatible, non-invasive, 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
Rx
true
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
07898966433306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07898966433306078989664333067898966433306

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic electrical bioimpedance system electrode array positionerA device designed to be attached to an adhesive belt-like electrode array to enable it to better fit the contours of a patient’s chest during thoracic electrical impedance tomography (EIT) or segmentography. It has a half-moon shape and is made of synthetic polymer materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
897939320
Device count
1
Lot or batch
true
Manufacturing 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
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
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