Home GUDID 05060038514424 Ambu WhiteSensor 0215M BIOTABSECG Electrodes
Primary DI 05060038514424
Brand Ambu WhiteSensor 0215M BIOTABSECG Electrodes
Company Ambu A/S
Model 0215M
Catalog number 0215M
Device description Ambu White Sensor 0215M Electrod with solid gel and polymer backing and tab connector. Radiolucent and MR Conditional. Packaging: 100 pouch/500 inner box/ 5000 carton
Published 2016-09-26
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Conditional
Rx true
Single use true Product Codes# Code, Name table Code Name DRX Electrode, electrocardiograph
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DRX Electrode, Electrocardiograph Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05060038511133 Package GS1 5 Not in Commercial Distribution 05060038513687 Package GS1 10 Not in Commercial Distribution 05060038514424 Primary GS1 0 05707480129133 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05060038511133 05060038511133 5060038511133 05060038513687 05060038513687 5060038513687 05060038514424 05060038514424 5060038514424 05707480129133 05707480129133 5707480129133
GMDN Terms# Term, Definition table Term Definition Electrocardiographic electrode, single-use A 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 Type Low High Condition Storage Environment Temperature 41 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 305682023 Device count 100 Premarket exempt true Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 05707480024438 Head Wedge™ 000264034 000264034 2022-12-08 05707480024476 Head Wedge™ 000264036 000264036 2022-12-08 05707480024490 Military Head Wedge™ 000264064 000264064 2022-12-08 05707480135363 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520611101 520611101 2017-10-13 05707480135585 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523631011 523631011 2018-07-09 05707480135615 SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 530639011 530639011 2017-10-13 05707480136018 SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544216047 544216047 2018-05-28 05707480145294 SPUR® II Adult Resuscitator 524614000 524614000 2020-06-24 05707480145317 SPUR® II Pediatric Resuscitator 531616000 531616000 2020-06-24 05707480145348 SPUR® II Adult Resuscitator 520611074 520611074 2020-06-24 05707480145393 SPUR® II Adult Resuscitator 520211000BE 520211000BE 2021-04-13 05707480145416 SPUR® II Adult Resuscitator 520211000E 520211000E 2021-04-13 05707480145430 SPUR® II Adult Resuscitator 520211001E 520211001E 2021-04-13 05707480145454 SPUR® II Adult Resuscitator 520211010E 520211010E 2021-04-13 05707480145478 SPUR® II Adult Resuscitator 520214000E 520214000E 2021-04-13 05707480145492 SPUR® II Adult Resuscitator 520611000E 520611000E 2021-04-13 05707480145515 SPUR® II Adult Resuscitator 521611000E 521611000E 2021-04-13 05707480145539 SPUR® II Adult Resuscitator 523211000E 523211000E 2021-04-13 05707480145553 SPUR® II Adult Resuscitator 523211001E 523211001E 2021-04-13 05707480145577 SPUR® II Adult Resuscitator 523611030E 523611030E 2021-04-13
Other Devices Sharing Product Codes# 
ambuusa.com