INNOSPIRE ESSENCE COMPRESSOR NEBULIZER SYSTEM, CUSTOM FOR FOCUS HOME MED

INNOSPIRE ESSENCE COMPRESSOR NEBULIZER SYSTEM, CUSTOM FOR FOCUS HOME MED
Innospire Essence - 1128182

An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BTI

Device Name: Compressor, Air, Portable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: AN

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: 868.6250

Third Party Flag: N

Medical Specialty: AN

Device Id: 00383730004037

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