Home GUDID B634MBR000211B1 Monarch Bronchoscope
Primary DI B634MBR000211B1
Brand Monarch Bronchoscope
Company AURIS HEALTH, INC.
Model MBR-000211-B
Catalog number MBR-000211-B
Device description Monarch Bronchoscope
Published 2021-05-13
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 QNW Reprocessed Bronchoscope
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QNW Reprocessed Bronchoscope Ear, Nose, Throat 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B634MBR000211B1 Package HIBCC 1 In Commercial Distribution B634MBR000211B0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Flexible video bronchoscope, reusable An endoscope with a flexible inserted portion for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It is inserted through the mouth or nose during bronchoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. It is commonly used to diagnose lung infections, pneumonia, or lung cancer, and allows physicians to view the insides of the lungs and take biopsies and samples of secretions. This is a reusable device.
Regulatory Flags# DUNS number 015823456 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch false Serial number true 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 10810068810940 MONARCH™ Advanced Imaging Accessory Kit MON-000709 MON-000709 2026-06-02 10810068810841 MONARCH™ Navigation Sensors MON-000705 MON-000705 2026-05-27 10810068810858 MONARCH™ Controller MON-000706 MON-000706 2026-05-27 10810068811046 MONARCH™Platform, Urology MON-000007 MON-000007 2026-05-05 10810068811053 Monarch® Ureteroscopy Kit MUR-000011 MUR-000011 2026-05-05 10810068811077 Monarch®Platform Drape Kit MUR-000013 MUR-000013 2026-05-05 10810068811084 MONARCH™ Kit Catheter & Accessories MUR-000014 MUR-000014 2026-05-05 10810068811114 MONARCH™ Mini-PCNL Suction Set MUR-000017 MUR-000017 2026-05-05 10810068811060 MONARCH™Guided Percutaneous Access Kit MUR-000012 MUR-000012 2026-05-04 10810068811091 MONARCH™ Stone Retrieval Basket MUR-000015 MUR-000015 2026-05-04 10810068811107 MONARCH™ Urology Irrigation Cartridge MUR-000016 MUR-000016 2026-05-04 10810068811121 MONARCH™ Ureteroscope Valve MUR-000026 MUR-000026 2026-05-04 10810068811138 MONARCH™ Bronchoscope MBR-000211-B MBR-000211-B 2026-04-21 10810068810896 Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished MON-000006-RFB 2025-08-04 10810068810988 Monarch Platform, Bronchoscopy 4.1 MON-000008 2025-03-03 10810068811169 Monarch Platform, Bronchoscopy 4.1, Refurbished MON-000008-RFB 2025-08-04 B634MON0007090 Monarch Advanced Imaging Accessory Kit MON-000709 MON-000709 2021-07-15 10810068810803 Monarch Bronchscope 2.0/Monarch Platform (P2) MON-000006 2024-05-05 B634MON00000501R0 Monarch Endoscopy Platform (P1) System, Refurbished MON-000005-01R 2020-03-25 B634MON000005010 Monarch Endoscopy Platform (P1) Tower Upgrade MON-000005-01 2020-07-13
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10810068811138 MONARCH™ Bronchoscope Auris Health, Inc. QNW 2026-04-21 B634MBR000211B0 Monarch Bronchoscope Auris Health, Inc. QNW 2021-05-13