Bronchoscope Fluidics Tubing MBR-000218

GUDID B634MBR0002180

Bronchoscope Fluidics Tubing

AURIS HEALTH, INC.

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• Primary Device ID: B634MBR0002180
• NIH Device Record Key: 00a9ff69-263c-4105-bd1d-359d9cfa16b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bronchoscope Fluidics Tubing
• Version Model Number: MBR-000218
• Catalog Number: MBR-000218
• 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: true
• Serial Number: false
• 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	B634MBR0002180 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-23
• Device Publish Date: 2021-11-15

On-Brand Devices [Bronchoscope Fluidics Tubing]

• B634MBR0000181: Bronchoscope Fluidics Tubing
• B634MBR0002180: Bronchoscope Fluidics Tubing