Vpap
Vpap Adapt SV AIR Delivery Syst
6manufacturers in China registered for this device type
7catalogue numbers in this listing
19510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (4), Beijing (1), Tianjin (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| BMC (Tianjin) Medical Co., Ltd. | Wuqing District | Tianjin | Contract manufacturer | 3 |
| Huizhou RSP Technology Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| BMC Medical Co., Ltd. | Fengtai District | Beijing | Specification developer | 3 |
Record
| Listed by | Resmed PTY Ltd., Australia |
|---|---|
| FDA product code | MNS |
| Device type | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-13 |
| Record revised | 2021-07-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 5 to 95 % RH; Storage environment temperature -4 to 140 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 26923 | In distribution | ||
| 26926 | 3 | In distribution | |
| 26925 | In distribution | ||
| 36034 | In distribution | ||
| 26924 | In distribution | ||
| 26931 | In distribution | ||
| 36039 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DreamStation | Respironics Inc. | 144 |
| AF531 | Respironics Inc. | 53 |
| BiPAP autoSV Advanced System One 60 Series | Respironics Inc. | 44 |
| BiPAP Avaps | Respironics Inc. | 35 |
| DreamStation BiPAP Avaps | Respironics Inc. | 30 |
| DreamMapper | Respironics Inc. | 27 |
| BiPAP A30 | Respironics Inc. | 25 |
| BiPAP S/T C-Series | Respironics Inc. | 19 |
| OmniLab Advanced Plus | Respironics Inc. | 19 |
| EncoreAnywhere | Respironics Inc. | 17 |
| DeVilbiss | DeVilbiss Healthcare LLC. | 15 |
| Ventilator, Continuous, Non-Life-Supporting | Salter Labs | 12 |
Showing 12 of 73. All products under Ventilator, Continuous, Non-Life-Supporting
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251889 | 2026-04-08 |
| K251661 | 2026-02-23 |
| K161492 | 2017-01-19 |
| K161487 | 2016-09-09 |
| K153061 | 2016-04-13 |
| K132371 | 2013-11-22 |
| K123511 | 2013-03-21 |
| K123557 | 2013-03-14 |
| K122324 | 2012-11-13 |
| K113714 | 2012-05-25 |
| K113288 | 2012-03-29 |
| K113815 | 2012-03-27 |
| K112914 | 2011-12-29 |
| K093731 | 2010-03-22 |
| K092186 | 2009-12-22 |
| K060105 | 2006-04-07 |
| K051364 | 2005-08-16 |
| K033276 | 2004-06-07 |
| K974417 | 1998-06-24 |
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.