Monarch™ Platform (Refurbished) MON000005R

GUDID B634MON000005R0

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

AURIS HEALTH, INC.

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• Primary Device ID: B634MON000005R0
• NIH Device Record Key: a2075dab-4cbb-448f-b40a-f58efd2a9f7c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch™ Platform (Refurbished)
• Version Model Number: MON000005R
• Catalog Number: MON000005R
• 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	B634MON000005R0 [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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• B634MON00000501R0 - Monarch Endoscopy Platform (P1) System, Refurbished: 2023-06-19 Monarch Endoscopy Platform (P1) System, Refurbished
• 10810068810476 - Monarch™ Software Tower v2.2.4: 2023-02-13 Monarch™ Software Tower v2.2.4
• 10810068810483 - Monarch™ Software Cart v2.2.4: 2023-02-13 Monarch™ Software Cart v2.2.4
• 10810068810490 - Monarch™ Laptop P70 Linux USB Image v2.2.4: 2023-02-13 Monarch™ Laptop P70 Linux USB Image v2.2.4