Home GUDID 05707480038220 9021S0235
Primary DI 05707480038220
Brand 9021S0235
Company Ambu A/S
Model 71002-SC/AP/12
Catalog number 71002-SC/AP/12
Device description 9021S0235 Surface Electrodes
Published 2020-05-19
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 Product Codes# Code, Name table Code Name GXY ELECTRODE, CUTANEOUS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GXY Electrode, Cutaneous Neurology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480038220 Package GS1 2 In Commercial Distribution 05707480038237 Package GS1 80 In Commercial Distribution 05707480143931 Package GS1 12 In Commercial Distribution 05707480038251 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480038220 05707480038220 5707480038220 05707480038237 05707480038237 5707480038237 05707480143931 05707480143931 5707480143931 05707480038251 05707480038251 5707480038251
GMDN Terms# Term, Definition table Term Definition Analytical non-scalp cutaneous electrode An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Device Sizes# Type, Value, Unit table Type Value Unit Length 20 Centimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 10 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 305682023 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 false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 05707480145591 SPUR® II Adult Resuscitator 523611031E 523611031E 2021-04-13 05707480027354 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211000 523211000 2016-12-19 05707480027361 SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523211001 523211001 2016-12-19
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