ReddyPort
Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1
6manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(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 | SMD Manufacturing LLC, United States |
|---|---|
| FDA product code | MNS |
| Device type | Ventilator, Continuous, Non-Life-Supporting |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K171827 |
| Record published | 2024-01-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Shelf carton box of 10, case of 5, shipper of 4, box of 10, case of 50, overshipper of 200 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RP-541-L2 | In distribution | |
| RP-541-SE | In distribution | |
| RP-541-L1 | In distribution | |
| RP-531-L1 | 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 |
|---|---|
| K231064 | 2023-07-13 |
| K171827 | 2018-01-19 |
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.