FDA.reportPublic FDA data

SHAPER No.1

Primary DI
07898959841262
Brand
SHAPER No.1
Company
Timpel S/A
Model
AD-05001
Published
2019-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07908715700020PackageGS110In Commercial Distribution
07898959841262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07908715700020079087157000207908715700020
07898959841262078989598412627898959841262

GMDN Terms#

Term, Definition table
TermDefinition
Electrical impedance skin electrode chest positionerA device designed to be adhered to a patient’s thoracic region to aid in the correct placement and positioning of cutaneous electrodes during breast electrical impedance (bioimpedance) spectroscopy [EIS/BIS], thoracic tomography (EIT) or segmentography procedures. It is available in various shapes (e.g., skin-adhesive star, belt) designed to better fit the contours of a patient’s chest and/or breast. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Storage Environment Temperature00

Contacts#

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

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
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