Portable Mesh Nebulizer

Basic Information

• Brand Name: Portable Mesh Nebulizer
• Primary DI: 06934325338705
• Version / Model: Air Pro VIII
• Company Name: FEELLIFE HEALTH INC.
• Labeler DUNS: 544431678
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-19
• Public Version: 2
• Public Version Date: 2023-02-09
• Public Version Status: Update
• Public Device Record Key: c6b86c44-e514-4d77-81b5-eb9d4edae35a
• Distribution End Date: 2023-02-08

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62042	Nebulizing system delivery set, reusable	A collection of non-sterile devices intended to be connected to a nebulizer system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patients respiratory system. It typically includes flexible tubing with connectors, a mask or mouthpiece, and a nebulizing medication chamber; pharmaceuticals are not included. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06934325338705	GS1

Premarket Submissions

Submission Number	Supplement Number
K182906	000