VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port

Basic Information

• Brand Name: VORTRAN PercussiveNEB 2.0 w/ Top Nebulizer Port
• Primary DI: 10637320080404
• Version / Model: 8040
• Catalog Number: 8040
• Company Name: VORTRAN MEDICAL TECHNOLOGY 1, INC
• Labeler DUNS: 090508636
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-02
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1db0aba4-d403-4b04-8faf-6fbcf223a9a6

Device Description

The PercussiveNEB 2.0 with Top Nebulizer Port is an intrapulmonary percussive treatment device that can incorporate a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NHJ	Device, Positive Pressure Breathing, Intermittent	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12719	Ultrasonic nebulizing system	An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20637320080401	GS1		10	In Commercial Distribution
Primary	10637320080404	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003684	000