Nebulizer Kit
Sunset SperaChamber - 10/Pack
3manufacturers in China registered for this device type
1catalogue number
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 | Sunset Healthcare Solutions, Inc., 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-01 |
| Record revised | 2025-09-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RES195 | 50 | 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 |
| 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 |
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.