Monarch Endoscopy Platform (P1) Tower Upgrade

GUDID B634MON000005010

Monarch Endoscopy Platform (P1) Tower Upgrade

AURIS HEALTH, INC.

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• Primary Device ID: B634MON000005010
• NIH Device Record Key: c4c48d2d-a17a-46c6-8929-c9e9d6bc47df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Endoscopy Platform (P1) Tower Upgrade
• Version Model Number: MON-000005-01
• 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	B634MON000005010 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [ Monarch Endoscopy Platform (P1) Tower Upgrade]

• B634MON00000501: Monarch Endoscopy Platform (P1) Tower Upgrade
• B634MON000005010: Monarch Endoscopy Platform (P1) Tower Upgrade