FDA.reportPublic FDA data

Ambu WhiteSensor

Primary DI
08906035283406
Brand
Ambu WhiteSensor
Company
MEDICO ELECTRODES INTERNATIONAL LIMITED
Model
2121M
Device description
Electrode skin abrasion pad
Published
2020-08-20
Public version status
New
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
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18906035283403PackageGS13In Commercial Distribution
28906035283400PackageGS110In Commercial Distribution
08906035283406PrimaryGS10
48906035283404Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890603528340318906035283403
2890603528340028906035283400
08906035283406089060352834068906035283406
4890603528340448906035283404

GMDN Terms#

Term, Definition table
TermDefinition
Electrode skin abrasion padA small, abrasive, hand-held device intended to be rubbed over select skin surface areas of a patient in preparation for placement of electrocardiograph (ECG) electrodes. It is used to remove superficial skin cells to enhance electrical contact (conductivity) for optimal ECG signals. It is typically used by emergency medical services (EMS). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature41 Degrees Fahrenheit86 Degrees Fahrenheit

Regulatory Flags#

DUNS number
677425215
Device count
500
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
18904450905740Medico Electrodes/ NeutralectNE135101X2026-04-17
18904450905757Medico Electrodes/ NeutralectNE135101SX2026-04-17
18904450905764Medico Electrodes/ NeutralectNE135101WX2026-04-17
18904450905771Medico Electrodes/ NeutralectNE135101SWX2026-04-17
18904450905788Medico Electrodes/ NeutralectNE189106X2026-04-17
18904450905795Medico Electrodes/ NeutralectNE189106SX2026-04-17
18904450905801Medico Electrodes/ NeutralectNE189106WX2026-04-17
18904450905818Medico Electrodes/ NeutralectNE189106SWX2026-04-17
08906035281044Ambu WhiteSensor0415M2020-08-20
08906035281174Ambu WhiteSensor3245D/RT/602020-08-20
08906035281501Ambu WhiteSensor0715M2020-08-20
08906035281525Ambu WhiteSensor0315M2020-08-20
08906035281532Ambu WhiteSensor0215M2020-08-20
08906035281549Ambu WhiteSensor0615M2020-08-20
08906035281587Ambu WhiteSensor4500M-H/32020-08-20
08906035281600Ambu WhiteSensor4535M2020-08-20
08906035282829Ambu WhiteSensorWS-00-S/502020-08-20
08906035282881Ambu WhiteSensor4500M2020-08-20
08906035282898Ambu WhiteSensor4560M2020-08-20
08906035282904Ambu WhiteSensor4570M2020-08-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20885380213202KendallCardinal Health 200, LLCDRX2026-08-18
10850078465006NIKOTRACENIKOMED USADRX2026-08-17
10850078465013NIKOTRACENIKOMED USADRX2026-08-17
10850078465020NIKOTRACENIKOMED USADRX2026-08-17
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
00851491007555AccuSensorLynn Medical Instrument Co.DRX2026-07-28
00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
00860002238500Piccolo MedicalPiccolo Medical, Inc.DRX2026-05-06
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
00860002238586Piccolo MedicalPiccolo Medical, Inc.DRX2025-11-07
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
20192253016748KendallCardinal Health 200, LLCDRX2021-05-19
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017349KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281525Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281532Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281549Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281587Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20