Monarch™ Bronchoscope System MBR-000011

GUDID B634MBR0000111

Monarch™ Bronchoscope System

AURIS HEALTH, INC.

Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use

• Primary Device ID: B634MBR0000111
• NIH Device Record Key: 51249d3b-b127-4ed2-9b09-3da9af09a991
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ Bronchoscope System
• Version Model Number: MBR-000011
• Catalog Number: MBR-000011
• Company DUNS: 015823456
• Company Name: AURIS HEALTH, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B634MBR0000110 [Primary]
HIBCC	B634MBR0000111 [Package]; Contains: B634MBR0000110; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173760

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-09
• Device Publish Date: 2018-06-08

Devices Manufactured by AURIS HEALTH, INC.

• 10810068810803 - Monarch Bronchscope 2.0/Monarch Platform (P2): 2024-05-13 The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) unde
• 20810068810831 - Bronchoscope Fluidics Tubing: 2024-05-13 Bronchoscope Fluidics Tubing
• 20810068810862 - Monarch Bronchoscope: 2024-05-13
• 20810068810879 - Bronchoscope Sheath Valve: 2024-05-13 Bronchoscope Sheath Valve
• 10810068810766 - Monarch™ Software Tower v2.2.5: 2024-02-26 Monarch™ Software Tower v2.2.5
• 10810068810773 - Monarch™ Software Cart v2.2.5: 2024-02-26 Monarch™ Software Cart v2.2.5
• 10810068810780 - Monarch™ Laptop P70 Linux USB Image v2.2.5: 2024-02-26 Monarch™ Laptop P70 Linux USB Image v2.2.5
• 10810068810797 - Monarch™ Laptop P17/P73 Linux USB Image v2.2.5: 2024-02-26 Monarch™ Laptop P17/P73 Linux USB Image v2.2.5