Monarch Platform, Bronchoscopy 4.1

GUDID 20810068810985

The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.

AURIS HEALTH, INC.

Robotic surgical arm system

• Primary Device ID: 20810068810985
• NIH Device Record Key: 6600cbf2-2309-4920-8fb6-eb1238628605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Platform, Bronchoscopy 4.1
• Version Model Number: MON-000008
• 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
GS1	10810068810988 [Primary]
GS1	20810068810985 [Package]; Contains: 10810068810988; Package: Crate [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243219

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-11
• Device Publish Date: 2025-03-03

Devices Manufactured by AURIS HEALTH, INC.

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• 10810068810599 - Monarch™ Cart Software v4.1.0: 2025-03-11 Monarch™ Cart Software v4.1.0
• 10810068810605 - Monarch™ Laptop P17 Software v4.1.0: 2025-03-11 Monarch™ Laptop P17 Software v4.1.0
• 10810068810612 - Monarch™ Laptop P16 Software v4.1.0: 2025-03-11 Monarch™ Laptop P16 Software v4.1.0
• 20810068810985 - Monarch Platform, Bronchoscopy 4.1: 2025-03-11The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) under continuous and direct control by a physician operator.
• 20810068810985 - Monarch Platform, Bronchoscopy 4.1: 2025-03-11 The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) unde
• 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