Ultrasonic Mini Nebulizer

Basic Information

• Brand Name: Ultrasonic Mini Nebulizer
• Primary DI: 00850027494364
• Version / Model: 1
• Company Name: HOME AIDE DIAGNOSTICS, INC.
• Labeler DUNS: 783518983
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 8b895f87-1b5a-4e74-8b42-3c04675e7682

Device Description

12ml ultrasonic, portable, nonventilatory atomizer mini nebulizer

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	868.5640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36857	Ultrasonic respiratory humidifier	A mains electricity (AC-powered) device designed to agitate water into micro-particles to add moisture to the flow of air/gases administered to a patient via a breathing tube/circuit.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850027494361	GS1	Outer Carton	32	In Commercial Distribution
Primary	00850027494364	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]