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510(k) Data Aggregation
K Number
K143719Device Name
Aeroneb USB Contoller System
Manufacturer
Aerogen Limited
Date Cleared
2015-07-10
(193 days)
Product Code
CAF
Regulation Number
868.5630Why did this record match?
Applicant Name (Manufacturer) :
Aerogen Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aerogen USB Controller System includes the Aeroneb® Professional and Aeroneb® Solo Nebulizers, which are intended to aerosolize physician-prescribed medications for inhalation to patients on and off ventilation or other positive pressure breathing assistance in the hospital environment, and on vent only in the homecare environment.
The Aeroneb® Professional Nebulizer is intended for multiple patient use in hospital environment and single patient use in home environment. Aeroneb® Solo Nebulizer is for single patient use. Both nebulizers are for pediatric (29 days or older) and adult patients.
Device Description
The Aerogen USB Controller System includes the previously cleared Aeroneb® Professional and Solo Nebulizers. The Aerogen USB Controller is an alternative controller to the existing Aeroneb® Pro and Aeroneb® Pro-X Controllers. The power source for the Aerogen USB Controller is the Aerogen USB AC/DC Adapter.
The Aerogen USB Controller System utilises the following components:
- Aeroneb® Pro or Solo Nebulizers
- Aerogen USB Controller
- T-Piece
- AC/DC Adapter and Clips
The Aerogen USB Controller can be used to power the Aeroneb® Pro and Solo nebulizers in both the hospital and homecare environments. For homecare use, it is operated on vent only.
The Aerogen USB Controller provides two modes of operation; a 30 minute and a 6 hour nebulization cycle. The particular mode to be used depends on the accompanying nebulizer. The Aeroneb Pro® nebulizer can be used in the 30 minute intermittent mode only, whereas the Aeroneb® Solo nebulizer can be used in both the 30 minute intermittent and 6 hour modes.
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