Bronchoscope

GUDID 00850048825000

The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures.

Noah Medical Corporation

Flexible video bronchoscope, reusable

• Primary Device ID: 00850048825000
• NIH Device Record Key: 2f59f236-3e83-4d9a-9cc4-ae40e912f347
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bronchoscope
• Version Model Number: 10000769
• Company DUNS: 117566482
• Company Name: Noah Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850048825000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223144

FDA Product Code

• EOQ: Bronchoscope (Flexible Or Rigid)

Sterilization

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

[00850048825000]

Ethylene Oxide

[00850048825000]

Ethylene Oxide

[00850048825000]

Ethylene Oxide

[00850048825000]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-19
• Device Publish Date: 2024-12-11

Devices Manufactured by Noah Medical Corporation

• 00850048825048 - Galaxy System: 2025-03-10 The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable br
• 00850048825055 - Accessory Kit: 2024-12-23 Galaxy system accessory kit
• 00850048825062 - Basic Accessory Kit: 2024-12-23 Galaxy system basic accessory kit
• 00850048825000 - Bronchoscope: 2024-12-19The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures.
• 00850048825000 - Bronchoscope: 2024-12-19 The Galaxy System and bronchoscopic is intended to provide visualization of patient airways for diagnostic procedures.
• 00850048825017 - Bronchoscope connector: 2024-12-19 Bronchoscope connector
• 00850048825031 - Bronchoscope guide: 2024-12-19 Scope guide
• 00000850048825 - Galaxy System: 2024-11-19 The Galaxy System is designed with the intent to enable articulation and precise control of a flexible, single-use disposable br