Nebu-Life

Basic Information

• Brand Name: Nebu-Life
• Primary DI: 00853292007475
• Version / Model: RTG-07100
• Catalog Number: RTG-07100
• Company Name: CUTTING EDGE HC BRANDS LLC
• Labeler DUNS: 080216804
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-25
• Public Version: 2
• Public Version Date: 2020-05-11
• Public Version Status: Update
• Public Device Record Key: d3ab55d1-eb36-4534-9b0f-9310e40f0733

Device Description

Nebu-Life Hand Held Nebulizer 6cc Cup. The Jet Nebulizer Bottle Set is used to administer various aerosal treatments to adults and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62680	Medicine chamber spacer, single-use	A non-sterile device intended to be placed between a nebulizer or a metered dose inhaler (MDI) and the patient's mouth, to function as a reservoir into which an aerosol medication is dispensed in order to minimize delivery of large aerosolized particles. It is typically made of plastic, paper, or cardboard and in the form of a small tube-like container. By holding the drug(s) after aerosolization (e.g., via an internal valve) this device reduces the direct delivery of large aerosolized particles which would otherwise be deposited in the mouth/upper airway, but are intended for the lower airway. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10853292007472	GS1	Carton	50	In Commercial Distribution
Primary	00853292007475	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K091272	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			6 cc Cup