Home GUDID 05707480136988 aScope™ 4 RhinoLaryngo Intervention
Primary DI 05707480136988
Brand aScope™ 4 RhinoLaryngo Intervention
Company Ambu A/S
Model 512001000
Catalog number 512001000
Device description Ambu aScope 4 RhinoLaryngo Intervention Single-use, flexible Rhinolaryngoscope Sterile from package. 2.2 mm working channel, outer diameter 5.0 mm, lenght of 350 mm. and a 130-degree bending angle. Minimum purchase 5 pcs = 1 box
Published 2019-09-06
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 EOB Nasopharyngoscope (flexible or rigid)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EOB Nasopharyngoscope (Flexible Or Rigid) Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480136964 Package GS1 4 In Commercial Distribution 05707480136988 Package GS1 5 In Commercial Distribution 05707480136971 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480136964 05707480136964 5707480136964 05707480136988 05707480136988 5707480136988 05707480136971 05707480136971 5707480136971
GMDN Terms# Term, Definition table Term Definition Flexible video rhinolaryngoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination of the upper airway structures which include the nasal passages, nasopharynx, oropharynx, and the larynx. It is inserted into the body through the mouth or a nostril and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Length 350 Millimeter Lumen/Inner Diameter 2 Millimeter Outer Diameter 5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 80 KiloPascal 106 KiloPascal Handling Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Storage Environment Atmospheric Pressure 50 KiloPascal 106 KiloPascal Storage Environment Humidity 10 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Humidity 30 Percent (%) Relative Humidity 85 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 25 Degrees Celsius Storage Environment Temperature 10 Degrees Celsius 40 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
Other Devices Sharing Product Codes# 
ambuusa.com