Extended Patient Introducer Mount MON-000713

GUDID 10810068811275

Extended Patient Introducer Mount

Auris Health, Inc.

Frame/rail/pole device holder

• Primary Device ID: 10810068811275
• NIH Device Record Key: 3ee4f23d-c98f-4420-84e5-8db47c0dae12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Extended Patient Introducer Mount
• Version Model Number: MON-000713
• Catalog Number: MON-000713
• 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: true
• Serial Number: false
• 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
GS1	10810068811275 [Primary]
GS1	20810068811272 [Package]; Package: Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243219

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: 2025-09-12
• Device Publish Date: 2025-09-04

Devices Manufactured by Auris Health, Inc.

• 10810068811275 - Extended Patient Introducer Mount: 2025-09-12Extended Patient Introducer Mount
• 10810068811275 - Extended Patient Introducer Mount: 2025-09-12 Extended Patient Introducer Mount
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• 20810068811166 - Monarch Platform, Bronchoscopy 4.1, Refurbished: 2025-08-12 The Monarch Bronchoscope enables electro-mechanical articulation and precise control of a flexible endoscope (bronchoscope) unde
• 10810068811497 - Monarch™ Tower Software v4.1.1: 2025-06-12 Monarch™ Tower Software v4.1.1
• 10810068811503 - Monarch™ Cart Software v4.1.1: 2025-06-12 Monarch™ Cart Software v4.1.1
• 10810068811510 - Monarch™ Laptop P17 Software v4.1.1: 2025-06-12 Monarch™ Laptop P17 Software v4.1.1
• 10810068811527 - Monarch™ Laptop P16 Software v4.1.1: 2025-06-12 Monarch™ Laptop P16 Software v4.1.1
• 10810068810971 - Monarch Endoscopy Controller: 2025-03-13 Monarch Endoscopy Controller