Protekt Nebulizer

Basic Information

• Brand Name: Protekt Nebulizer
• Primary DI: 05060488573606
• Version / Model: PMNEBRDK-OT
• Catalog Number: PMNEBRDK-OT
• Company Name: PROACTIVE MEDICAL PRODUCTS, LLC
• Labeler DUNS: 078582655
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-18
• Public Version: 1
• Public Version Date: 2022-11-28
• Public Version Status: New
• Public Device Record Key: c518bca0-a5fe-4177-8c5c-a18a8d605370

Device Description

Protekt Pediatric Nebulizer w/ Disposable and Reusable Neb Kit, w/ Pediatric Mask - Orange Tiger

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: 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
12716	Benchtop nebulizer, heated	An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060488573613	GS1	Pack	10	In Commercial Distribution
Primary	05060488573606	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K123030	000

Device Sizes

Type	Value	Unit	Text
Length	6	Inch
Height	8	Inch
Width	9	Inch