Monarch Bronchoscope MRB-000211-A

GUDID 20810068810862

AURIS HEALTH, INC.

Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use

• Primary Device ID: 20810068810862
• NIH Device Record Key: 1285c582-33c6-40ea-a727-7dc44235dd7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monarch Bronchoscope
• Version Model Number: MBR-000211-A
• Catalog Number: MRB-000211-A
• 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
GS1	10810068810865 [Primary]
GS1	20810068810862 [Package]; Contains: 10810068810865; Package: Shelf Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193534

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

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: 2024-05-13
• Device Publish Date: 2024-05-05

On-Brand Devices [Monarch Bronchoscope]

• B623MBR000211A0: Monarch Bronchoscope
• B634MBR000211A1: MBR-000211-A
• B634MBR000211B1: Monarch Bronchoscope
• 20810068810862: MBR-000211-A