Monarch Bronchoscope MBR-000211-B

GUDID B634MBR000211B1

Monarch Bronchoscope

AURIS HEALTH, INC.

Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable Flexible video bronchoscope, reusable

• Primary Device ID: B634MBR000211B1
• NIH Device Record Key: 1286f1d6-065a-41c7-b223-e10d90a0e453
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Bronchoscope
• Version Model Number: MBR-000211-B
• Catalog Number: MBR-000211-B
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• 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	B634MBR000211B0 [Primary]
HIBCC	B634MBR000211B1 [Package]; Contains: B634MBR000211B0; Package: Box [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203614

FDA Product Code

• QNW: Reprocessed Bronchoscope

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-21
• Device Publish Date: 2021-05-13

On-Brand Devices [Monarch Bronchoscope]

• B623MBR000211A0: Monarch Bronchoscope
• B634MBR000211A1: MBR-000211-A
• B634MBR000211B1: Monarch Bronchoscope