Home GUDID 05707480157426
aScope™ Duodeno
Primary DI 05707480157426
Brand aScope™ Duodeno
Company Ambu A/S
Model 482001000/4
Catalog number 482001000/4
Device description aScope Duodeno (box of 4 pcs)
Published 2022-04-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true
Product Codes# Code, Name table Code Name FDT Duodenoscope and accessories, flexible/rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDT Duodenoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480157426 Package GS1 4 In Commercial Distribution 05707480157402 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480157426 05707480157426 5707480157426 05707480157402 05707480157402 5707480157402
GMDN Terms# Term, Definition table Term Definition Endoscopic video image processing unit An electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 30 Percent (%) Relative Humidity 80 Percent (%) Relative Humidity Handling Environment Temperature -5 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity 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 false Sterilization required before use false 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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