VISIONAIR

GUDID 00860009626805

The VISIONAIR™ system is a software application intended to be used with third-party endoscopic systems in the measurement of the nasal respiratory airway. The VISIONAIR™ system measures the nasal respiratory airway from the endoscopic images taken in the region of the internal nasal valve (INV) and nasal cavum (NC).

PACIFICMD BIOTECH, LLC

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• Primary Device ID: 00860009626805
• NIH Device Record Key: 24abe5d5-d83d-461b-adc3-e885bf1a1b1f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VISIONAIR
• Version Model Number: 2
• Company DUNS: 093528241
• Company Name: PACIFICMD BIOTECH, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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	00860009626805 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221892

FDA Product Code

• BXQ: Rhinoanemometer (Measurement Of Nasal Decongestion)

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: 2023-02-15
• Device Publish Date: 2023-02-07