DeVilbiss
Part Sleep Flow Generator Accessories Product Description SLEEP CASE REPAIR KIT
6manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | DeVilbiss Healthcare LLC., United States |
|---|---|
| FDA product code | MNS |
| Device type | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Repacker / relabeller, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2024-01-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C |
| Packaging | Pack of 4 |
| Distribution end date | 2024-11-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DV56D-HH-HT | Withdrawn | |
| DV56I-670 | Withdrawn | |
| DV56UK | Withdrawn | |
| DV56D-HH | Withdrawn | |
| DV56D-673 | Withdrawn | |
| DV56D | Withdrawn | |
| DV56BR | Withdrawn | |
| DV56D-S | Withdrawn | |
| DV56D-HH-S | Withdrawn | |
| DV56SE-HH | Withdrawn | |
| DV56NE | Withdrawn | |
| DV56NE-HH | Withdrawn | |
| DV56BR-HH | Withdrawn | |
| DV56D-HH-S-HT | Withdrawn | |
| DV56SE | Withdrawn |
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 |
| Ventilator, Continuous, Non-Life-Supporting | Salter Labs | 12 |
| DreamStation BiPAP autoSV | Respironics Inc. | 12 |
Showing 12 of 73. All products under Ventilator, Continuous, Non-Life-Supporting
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.