Home GUDID 05707480154807 aScope™ Colon
Primary DI 05707480154807
Brand aScope™ Colon
Company Ambu A/S
Model 484001000US
Catalog number 484001000US
Device description aScope Colon US version
Published 2023-11-02
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 FDF Colonoscope and accessories, flexible/rigid
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FDF Colonoscope And Accessories, Flexible/Rigid Gastroenterology, Urology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480154807 Package GS1 6 In Commercial Distribution 05707480154791 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480154807 05707480154807 5707480154807 05707480154791 05707480154791 5707480154791
GMDN Terms# Term, Definition table Term Definition Flexible video colonoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). 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.
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 Humidity 10 Percent (%) Relative Humidity 95 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 05707480167579 Ambu® Neuroline Monopolar 74225-36/40 74225-36/40 2026-09-05 05707480167593 Ambu® Neuroline Monopolar 74225-36/40 74225-36/40 2026-09-05 05707480167609 Ambu® Neuroline Monopolar 74238-36/40 74238-36/40 2026-09-05 05707480167630 Ambu® Neuroline Monopolar 74325-36/40 74325-36/40 2026-09-05 05707480167661 Ambu® Neuroline Monopolar 74338-36/40 74338-36/40 2026-09-05 05707480145287 aScope™ Duodeno 482001000 482001000 2020-08-10 05707480157402 aScope™ Duodeno 482001000/4 482001000/4 2022-04-19 05707480136032 Isiris™ Monitor MN0001 MN0001 2018-07-30 05707480156306 aScope™ 5 Broncho HD 5.0/2.2 621001000US 621001000US 2022-08-19 05707480156337 aScope™ 5 Broncho HD 5.6/2.8 622001000US 622001000US 2022-08-19 05707480157259 aScope™ 5 Broncho 4.2/2.2 620001000US 620001000US 2023-08-25 05707480157280 aScope™ 5 Broncho 2.7/1.2 624001000US 624001000US 2023-08-25 05060038511034 Ambu® WhiteSensor 40554 40554 40554 2026-08-07 05707480024650 Ambu® Mini Perfit ACE™ 000281106 000281106 2022-12-08 05707480024674 Ambu® Immobilization Kit, with 000281161 000281161 2022-12-08 05707480026197 BlueSensor NEOXECG Electrodes NEOX-60-K/US/3 NEOX-60-K/US/3 2016-09-21 05707480024513 Ambu® Perfit Collar™ 000264201 000264201 2022-12-08 05707480024520 Ambu® Perfit Collar™ 000264202 000264202 2022-12-08 05707480024537 Ambu® Perfit Collar™ 000264203 000264203 2022-12-08 05707480024544 Ambu® Perfit Collar™ 000264204 000264204 2022-12-08
Other Devices Sharing Product Codes# 
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