Aerochamber Plus® Flow-Vu®
AeroChamber Plus Flow-Vu is an anti-static valved holding chamber used between a metered-dose inhaler and an interface such as a mask or mouthpiece. The chamber holds aerosol briefly so it…
AeroChamber Plus Flow-Vu is an anti-static valved holding chamber used between a metered-dose inhaler and an interface such as a mask or mouthpiece. The chamber holds aerosol briefly so it can be inhaled from the inhaler through the chamber.
The filed 50412 example has an intermediate mask. The Flow-Vu indicator moves with inhalation, giving a visible cue that the chamber is responding to a breath.
Listed Item
AC Plus, Flow-Vu aVHC, Intermediate Mask, Retail – 50412
Chamber and Mask
The chamber connects to a metered-dose inhaler and holds aerosol before it is inhaled through a mask or mouthpiece. Its valve supports the inhalation pathway between inhaler and interface.
AeroChamber configurations differ by mask size or mouthpiece. The filed 50412 example pairs the chamber with an intermediate mask, while other family versions use different interfaces.
Who Else Makes It
Concentrated in Guangdong (2), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Koo (Shanghai) Industries Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 9 |
Record
| Listed by | Monaghan Medical Corp., United States |
|---|---|
| FDA product code | NVP |
| Device type | Holding Chambers, Direct Patient Interface |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| 510(k) | K112010 |
| Record published | 2016-09-19 |
| Record revised | 2023-10-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Pack of 10, pack of 12, pack of 50 |
| Distribution end date | 2023-10-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| aVHC, Large Mask, cs/10 | In distribution | |
| aVHC, Intermediate Mask, cs/12 | In distribution | |
| aVHC, Mouthpiece, cs/10 | In distribution | |
| aVHC, Mouthpiece, cs/12 | In distribution | |
| aVHC, Mouthpiece Demo, Allergan, Single | In distribution | |
| aVHC, Mouthpiece, Allergan, Single | In distribution | |
| aVHC, Large Mask Demo, Allergan, Single | In distribution | |
| aVHC, Medium Mask, Allergan, Single | In distribution | |
| aVHC, Medium Mask Demo, Allergan, Single | In distribution | |
| aVHC, Medium Mask, cs/12 | In distribution | |
| aVHC, Large Mask, cs/12 | In distribution | |
| aVHC, Mouthpiece, cs/50 | In distribution | |
| aVHC, Intermediate Mask, cs/10 | In distribution | |
| aVHC, Small Mask, cs/10 | In distribution | |
| aVHC, Large Mask, Allergan, Single | In distribution | |
| aVHC, Medium Mask, cs/10 | In distribution | |
| aVHC, Small Mask, cs/12 | In distribution | |
| aVHC, Small Mask, Allergan, Single | In distribution | |
| aVHC, Small Mask Demo, Allergan, Single | In distribution | |
| aVHC, Large Mask, NFR, Single | Withdrawn | |
| aVHC, Medium Mask, NFR, Single | Withdrawn | |
| aVHC, Small Mask, NFR, Single | Withdrawn | |
| aVHC, Mouthpiece, NFR, Single | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| OptiChamber Diamond | Respironics Respiratory Drug Delivery (Uk), Ltd. | 8 |
| InspiraChamber Valved Holding Chamber | Inspirx, Inc. | 8 |
| Aerochamber Plus® Z Stat® | Monaghan Medical Corp. | 5 |
| Monaghan™ Z Stat® | Monaghan Medical Corp. | 5 |
| InspiraChamber® | Clement Clarke Intl., Ltd. | 5 |
| VentiChamber | Clement Clarke Intl., Ltd. | 5 |
| Clever Choice | Simple Diagnostics | 3 |
| Flexichamber | Avadel Pharmaceuticals (USA), Inc. | 2 |
| Breathe Comfort | Slv Pharmaceuticals LLC | 2 |
| Flexichamber | Cerecor Inc. | 2 |
| InspiraChamber® | Flexicare Medical Ltd. | 2 |
| Aerochamber2go Anti-Static Valved Holding Chamber | Monaghan Medical Corp. | 1 |
Showing 12 of 38. All products under Holding Chambers, Direct Patient Interface
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.