VORTRAN PercussiveNEB

Basic Information

• Brand Name: VORTRAN PercussiveNEB
• Primary DI: 10637320040309
• Version / Model: PNB-4030
• Catalog Number: PNB-4030
• 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: 2016-06-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e1843de4-b1d1-4056-96a9-77a080e725dd

Device Description

The PercussiveNEB® device is a single-patient use percussor, which makes it possible for individuals to receive multiple high frequency treatments while using the same device. Other percussive devices need to be cleaned between patients and also require waiting for the equipment to become available. It is easy to use with quick set-up time and patient initiates and controls the percussion levels. It can be used by patients in the hospital or in the home

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: No
• 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	20637320040306	GS1		10	In Commercial Distribution
Primary	10637320040309	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K003684	000