Portable Mesh Nebulizer

GUDID 06934325302263

FEELLIFE HEALTH INC.

Benchtop nebulizer, non-heated

• Primary Device ID: 06934325302263
• NIH Device Record Key: 346e1d23-2c58-41f5-844f-ff2bc489484b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Mesh Nebulizer
• Version Model Number: AirICU
• Company DUNS: 544431678
• Company Name: FEELLIFE HEALTH INC.
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	06934325302263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182906

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: 2023-02-16
• Device Publish Date: 2023-02-08

On-Brand Devices [Portable Mesh Nebulizer]

• 06934325388540: Air Angel
• 06934325380353: Air Pro IX
• 06934325376950: Aerogo
• 06934325371733: Air Mask II
• 06934325358475: Air Pro
• 06934325349237: Air Pro III
• 06934325338705: Air Pro VIII
• 06934325322278: Air Kids
• 06934325319490: AeroCentre+
• 06934325301846: Air Plus
• 06934325302263: AirICU
• 06934325302249: Air Mask D