Bronchoscope Fluidics Tubing MBR-000218

GUDID 20810068810831

Bronchoscope Fluidics Tubing

AURIS HEALTH, INC.

Surgical irrigation tubing set, single-use

• Primary Device ID: 20810068810831
• NIH Device Record Key: f8545700-c14a-4d9d-89f7-e69fe89965dc
• 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
GS1	10810068810834 [Primary]
GS1	20810068810831 [Package]; Contains: 10810068810834; Package: Shelf Carton [3 Units]; In Commercial Distribution

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

On-Brand Devices [Bronchoscope Fluidics Tubing]

• B634MBR0000181: Bronchoscope Fluidics Tubing
• B634MBR0002180: Bronchoscope Fluidics Tubing
• 20810068810831: Bronchoscope Fluidics Tubing