Electro Flo® Percussor

GUDID 00862528000302

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.

MED SYSTEMS INC

Chest-percussion airway secretion-clearing system control unit

• Primary Device ID: 00862528000302
• NIH Device Record Key: 5ec53058-d5f4-47e3-894d-d962df482f61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electro Flo® Percussor
• Version Model Number: 5000
• Company DUNS: 039978200
• Company Name: MED SYSTEMS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 858 483-9671
• Email: susan@medsystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862528000302 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031876

FDA Product Code

• BYI: Percussor, Powered-Electric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-28
• Device Publish Date: 2019-03-20

Devices Manufactured by MED SYSTEMS INC

• 00862528000319 - FluidFlo: 2023-09-13 FluidFlo Pneumatic percussor.
• 00862528000326 - Med Systems small mask.: 2023-09-13 Med Systems small mask.
• 00862528000333 - Med Systems medium mask.: 2023-09-13 Med Systems medium mask.
• 00862528000340 - Med Systems large mask.: 2023-09-13 Med Systems large mask.
• 00862528000302 - Electro Flo® Percussor: 2019-03-28The 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.
• 00862528000302 - Electro Flo® Percussor: 2019-03-28 The Electro Flo 5000 is an electrically powered percussor, intended to assist in airway clearance therapy when the physician’s