Electro Flo® Percussor

Basic Information

• Brand Name: Electro Flo® Percussor
• Primary DI: 00862528000302
• Version / Model: 5000
• Company Name: MED SYSTEMS INC
• Labeler DUNS: 039978200
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-20
• Public Version: 1
• Public Version Date: 2019-03-28
• Public Version Status: New
• Public Device Record Key: 5ec53058-d5f4-47e3-894d-d962df482f61

Device Description

The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s choice of therapy is external manipulation of the thorax. Additionally, the Electro Flo 5000 is indicated for external manipulation of the thorax to promote airway clearance and improve bronchial drainage.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• 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
BYI	Percussor, Powered-Electric	Anesthesiology	868.5665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45339	Chest-percussion airway secretion-clearing system control unit	A mains electricity (AC-powered) component of a chest-percussion airway secretion-clearing system designed to regulate the amount of power delivered to the system's applicator and the speed at which the percussion is delivered.	No	Active
38045	Chest-percussion airway secretion-clearing system applicator	A hand-held component of a chest-percussion airway secretion-clearing system that is applied by a healthcare professional or trained helper to a patient's chest wall (child to adult) to deliver percussion (rapid tapping) to help loosen bronchial mucus for expectoration. It is connected to the system's control unit that regulates the input power and speed of percussion; it is often referred to as a ?hand-held hammer?.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00862528000302	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K031876	000

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 32 – 158 Degrees Fahrenheit