Monarch Endoscopy Platform (P1) System, Refurbished

GUDID B634MON00000501R0

Monarch Endoscopy Platform (P1) System, Refurbished

AURIS HEALTH, INC.

Robotic surgical arm system

• Primary Device ID: B634MON00000501R0
• NIH Device Record Key: 918c4fb6-ba98-4952-8212-ef6bc52f828d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Endoscopy Platform (P1) System, Refurbished
• Version Model Number: MON-000005-01R
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• 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	B634MON00000501R0 [Primary]

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: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-19
• Device Publish Date: 2020-03-25

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