AireHealth Nebulizer

GUDID 00860002180618

AIREHEALTH LLC

Ultrasonic nebulizing system

• Primary Device ID: 00860002180618
• NIH Device Record Key: de378cbf-fcbc-43bb-8e1a-0e9b312c30b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AireHealth Nebulizer
• Version Model Number: AH-04
• Company DUNS: 111359906
• Company Name: AIREHEALTH LLC
• 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: 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	00860002180618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201167

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [AireHealth Nebulizer]

• 00860002180601: AH03
• 00860002180618: AH-04