Home GUDID 05707480121359 Zmachine Comfort 40
Primary DI 05707480121359
Brand Zmachine Comfort 40
Company Ambu A/S
Model 72000-S/GSC/3
Catalog number 72000-S/GSC/3
Device description Single-Use Ag/AgCl Surface Sensors
Published 2022-12-08
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
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 05707480121335 Package GS1 8 In Commercial Distribution 05707480121342 Package GS1 13 In Commercial Distribution 05707480121359 Primary GS1 0 05707480153992 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 05707480121335 05707480121335 5707480121335 05707480121342 05707480121342 5707480121342 05707480121359 05707480121359 5707480121359 05707480153992 05707480153992 5707480153992
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.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 10 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 305682023 Device count 3 Lot or batch true Expiration date on label 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
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