FDA.reportPublic FDA data

Ambu WhiteSensor

Primary DI
08906035283123
Brand
Ambu WhiteSensor
Company
MEDICO ELECTRODES INTERNATIONAL LIMITED
Model
7841P/5
Device description
Electrocardiographic electrode, single use
Published
2020-08-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
18906035283120PackageGS1150In Commercial Distribution
28906035283127PackageGS16In Commercial Distribution
08906035283123PrimaryGS10
48906035283121Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1890603528312018906035283120
2890603528312728906035283127
08906035283123089060352831238906035283123
4890603528312148906035283121

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiographic electrode, single-useA non-sterile, noninvasive electrical conductor designed to conduct electrical signals, generated by a patient's heart, from the skin surface to an electrocardiograph (ECG) monitoring device, via an ECG lead wire (not included). It is typically a disk-like electrode that is affixed to the skin with a special adhesive, adhesive tape, or suction mechanism; a conductive gel may be pre-applied and it may include a skin cleaning wipe to assist electrical connection. Electrocardiography is usually performed using a set of electrodes (e.g., 10) connected to appropriate leads and cables. 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
5
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
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
08033003267424NAFIAB SPADRX2021-03-31
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
08906035281600Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282829Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282881Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282898Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282904Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282966Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282980Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283017Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283024Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283048Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283055Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283062Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283079Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283086Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283093Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283109Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035283147Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20