Aerochamber Plus® Z Stat®
5 catalogue numbers from aVHC, Mouthpiece, cs/10, listed by Monaghan Medical Corp., United States, under Holding Chambers, Direct Patient Interface. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
5catalogue numbers in this listing
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) | K052332 |
| Record published | 2016-09-26 |
| Record revised | 2021-09-09 (version 4) |
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 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| aVHC, Mouthpiece, cs/10 | In distribution | |
| aVHC, Small Mask, cs/10 | In distribution | |
| aVHC, Medium Mask, cs/10 | In distribution | |
| aVHC, Mouthpiece, cs/50 | In distribution | |
| aVHC, Large Mask, cs/10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aerochamber Plus® Flow-Vu® | Monaghan Medical Corp. | 23 |
| OptiChamber Diamond | Respironics Respiratory Drug Delivery (Uk), Ltd. | 8 |
| InspiraChamber Valved Holding Chamber | Inspirx, Inc. | 8 |
| 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.