FDA.reportPublic FDA data

Flexible video bronchoscope, single-use

Definition
A sterile 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 commonly intended for flexible optical intubation, airway inspection, and may assist other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.
GUDID devices
66
Last updated
2022-11-08 09:31:49

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05707480158119aScope™ 4 Broncho Large 5.8/2.8Ambu A/S4781770002022-10-31
05707480158089aScope™ 4 Broncho Regular 5.0/2.2Ambu A/S4771770002022-09-23
05707480158058aScope™ 4 Broncho Slim 3.8/1.2Ambu A/S4761770002022-09-21
05707480156320aScope™ 5 Broncho HD 5.0/2.2 Sampler SetAmbu A/S621001000US2022-08-19
05707480156344aScope™ 5 Broncho HD 5.6/2.8 Sampler SetAmbu A/S622001000US2022-08-19
06972197480016Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-022022-06-13
06972197480023Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-C22022-06-13
06972197480030Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-M22022-06-13
06972197480047Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-S22022-06-13
06972197480054Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-W22022-06-13
06972197480078Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-012022-06-13
06972197480085Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-C12022-06-13
06972197480092Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-M12022-06-13
06972197480108Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-S12022-06-13
06972197480115Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-W12022-06-13
06972197480122Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-H12022-06-13
06972197480139Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-H22022-06-13
06972197480146Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-K12022-06-13
06972197480153Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-K22022-06-13
06972197480160Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-O12022-06-13
06972197480177Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-O22022-06-13
06972197480184Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-U12022-06-13
06972197480191Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-U22022-06-13
06972197480511Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-S22022-06-13
06972197480528Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-M22022-06-13
06972197480535Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-C22022-06-13
06972197480542Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-022022-06-13
06972197480559Single-Use flexible Video BronchoscopeHunan Vathin Medical Instrument Co., LtdBCV1-W22022-06-13
10879123007534GlideScope®VERATHON INCBFlex™ 2.82022-04-19
06970034210390InnovexShanghai AnQing Medical Instrument Co., LtdBS41H-12EU2021-12-09
06970034210406InnovexShanghai AnQing Medical Instrument Co., LtdBS46H-17EU2021-12-09
06970034210413InnovexShanghai AnQing Medical Instrument Co., LtdBS50H-20EU2021-12-09
06970034210420InnovexShanghai AnQing Medical Instrument Co., LtdBS53H-22EU2021-12-09
06970034210437InnovexShanghai AnQing Medical Instrument Co., LtdBS55H-24EU2021-12-09
06970034210444InnovexShanghai AnQing Medical Instrument Co., LtdBS59H-28EU2021-12-09
06970034210451InnovexShanghai AnQing Medical Instrument Co., LtdBS41H-12US2021-12-09
06970034210468InnovexShanghai AnQing Medical Instrument Co., LtdBS46H-17US2021-12-09
06970034210475InnovexShanghai AnQing Medical Instrument Co., LtdBS50H-20US2021-12-09
06970034210482InnovexShanghai AnQing Medical Instrument Co., LtdBS53H-22US2021-12-09
06970034210499InnovexShanghai AnQing Medical Instrument Co., LtdBS55H-24US2021-12-09
06970034210505InnovexShanghai AnQing Medical Instrument Co., LtdBS59H-28US2021-12-09
05707480145966aScope™ 4 Broncho Regular Sampler Set 5.0/2.2Ambu A/S4775010002021-09-16
05707480146000aScope™ 4 Broncho Large Sampler Set 5.8/2.8Ambu A/S4785010002021-09-16
00191506007430EXALT™ Model BBOSTON SCIENTIFIC CORPORATIONM005427102021-08-24
00191506007461EXALT™ Model BBOSTON SCIENTIFIC CORPORATIONM005427302021-08-24
00191506007492EXALT™ Model BBOSTON SCIENTIFIC CORPORATIONM005427502021-08-24
00886874121184IonINTUITIVE SURGICAL, INC.4902062021-05-06
B634MBR000211A1Monarch BronchoscopeAURIS HEALTH, INC.MBR-000211-A2021-05-05
B623MBR000211A0Monarch BronchoscopeAuris Health, Inc.MBR-000211-A2021-03-17
03664977010034Broncoflex VortexAXESS VISION TECHNOLOGY100300012020-12-10
03664977020033Broncoflex AgileAXESS VISION TECHNOLOGY200300012020-12-10
03664977030032ScreeniAXESS VISION TECHNOLOGY300300012020-12-10
10879123006339GlideScope® VERATHON INCBFlex™ 5.02019-08-01
10879123006407GlideScope® VERATHON INCBFlex™ 5.82019-08-26
00851545007562NeoscopePROSURG INCNBF 502016-09-23
00851545007579NeoscopePROSURG INCNBF 652016-09-23
10879123006391GlideScope® VERATHON INCBFlex™ 3.82020-02-07
B634MBR0000111Monarch™ Bronchoscope SystemAURIS HEALTH, INC.MBR-0000112018-06-08
05707480121977aScope™ 3 Slim 3.8/1.2Flexible Videoscope - SinglAmbu A/S4020010002016-09-21
05707480122011aScope™ 3 Regular 5.0/2.2Flexible Videoscope - SiAmbu A/S4030010002016-09-21
05707480133116aScope™ 3 Large 5.8/2.8Flexible Videoscope - SinglAmbu A/S4140010002016-09-21
05707480135486aScope™ 4 Broncho Slim 3.8/1.2Flexible Endoscope - Single UseAmbu A/S4760010002018-07-04
05707480135523aScope™ 4 Broncho Regular 5.0/2.2Flexible Endoscope - Single UseAmbu A/S4770010002018-07-04
05707480135547aScope™ 4 Broncho Large 5.8/2.8Flexible Endoscope - Single UseAmbu A/S4780010002018-07-04
10886874116125IonINTUITIVE SURGICAL, INC.4901062019-03-21
00815686020729View Optical ProbeVERAN MEDICAL TECHNOLOGIES INC.INS-55002016-08-31