InspiraChamber Valved Holding Chamber
InspiraChamber Anti-Static Valved Holding Chamber (Teleflex Medical) 1001-10
3manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
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 | Inspirx, Inc., United States |
|---|---|
| FDA product code | NVP |
| Device type | Holding Chambers, Direct Patient Interface |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| 510(k) | K130598 |
| Record published | 2019-12-11 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 10, case of 50, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1001-10SS | In distribution | |
| 1001-10S | In distribution | |
| 1001-10 | In distribution | |
| 1001-10M | In distribution | |
| 1001-10L | In distribution | |
| 1001-50 | In distribution | |
| 1001-10SM | In distribution | |
| IC-VHC-0 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130598 | 2013-06-05 |
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.