Home GUDID 05707480156481 aScope™ 5 Broncho 4.2/2.2 Sampler Set
Primary DI 05707480156481
Brand aScope™ 5 Broncho 4.2/2.2 Sampler Set
Company Ambu A/S
Model 620002000US
Catalog number 620002000US
Device description Flexible Endoscope and Specimen Sampling System
Published 2023-11-26
Public version status Update
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 EOQ Bronchoscope (flexible or rigid)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 05707480156498 Package GS1 5 In Commercial Distribution 05707480156504 Package GS1 4 In Commercial Distribution 05707480156481 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 05707480156498 05707480156498 5707480156498 05707480156504 05707480156504 5707480156504 05707480156481 05707480156481 5707480156481
GMDN Terms# Term, Definition table Term Definition Flexible video bronchoscope, single-use An endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 0 Lumen/Inner Diameter 0 Outer Diameter 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Atmospheric Pressure 0 0 Handling Environment Humidity 0 0 Handling Environment Temperature 0 0 Storage Environment Atmospheric Pressure 0 0 Storage Environment Humidity 0 0 Storage Environment Temperature 0 0
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 true 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 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 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 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
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