INNOVA

INNOVA - UPG X100 001

A tightly-fitting garment-like device that is a component of a high frequency chest wall oscillation airway secretion-clearing system and which is designed to be worn by a patient to encompass the thorax during high frequency chest wall oscillation (HFCWO) treatment. It is connected via a dedicated thick-walled hose to the system's generator which rapidly inflates and deflates the vest against the chest wall to promote airway clearance by creating HFCWO resulting in the mobilization of bronchial secretions. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: IZI

Device Name: System, X-Ray, Angiographic

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1600

Third Party Flag: N

Medical Specialty: RA

Code: OWB

Device Name: Interventional Fluoroscopic X-Ray System

Device Class: 2

Physical State: Fluoroscopic X-Ray system

Definition: Interventional fluoroscopy

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Fluoroscopy

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Human body

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Code: JAA

Device Name: System, X-Ray, Fluoroscopic, Image-Intensified

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: RA

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 892.1650

Third Party Flag: Y

Medical Specialty: RA

Device Id: 00840682121637

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A