Monarch™ Software Cart v2.1.4

GUDID B634SW0032750201040

Monarch™ Software Cart v2.1.4

AURIS HEALTH, INC.

Robotic surgical system application software

• Primary Device ID: B634SW0032750201040
• NIH Device Record Key: 8fe3ba9f-96bc-48e6-a47c-3eaefdc34fc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ Software Cart v2.1.4
• Version Model Number: Version 2.1.4
• 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: false
• Manufacturing Date: false
• 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	B634SW0032750201040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173760

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2019-05-20
• Device Publish Date: 2019-05-10

Devices Manufactured by AURIS HEALTH, INC.

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• 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