Fisher & Paykel Healthcare
Nivairo+ RT055 Non-Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version- Extra Small
4manufacturers in China registered for this device type
25catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Respironics Medical Products (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
Record
| Listed by | Fisher & Paykel Healthcare, Ltd., New Zealand |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K060044 |
| Record published | 2022-08-02 |
| Record revised | 2026-03-16 (version 6) |
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, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 50 °C |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| RT057XS | EXTRA SMALL | In distribution |
| RT043M | MEDIUM | In distribution |
| RT040S | SMALL | In distribution |
| RT047S | SMALL | In distribution |
| RT057L | LARGE | In distribution |
| RT045XS | Extra Small | In distribution |
| RT055XS | EXTRA SMALL | In distribution |
| RT055L | LARGE | In distribution |
| RT057S | SMALL | In distribution |
| RT057M | MEDIUM | In distribution |
| RT040M | MEDIUM | In distribution |
| RT045M | Medium | In distribution |
| RT040L | LARGE | In distribution |
| RT055M | MEDIUM | In distribution |
| RT045L | Large | In distribution |
| RT047L | LARGE | In distribution |
| RT047M | MEDIUM | In distribution |
| RT043L | LARGE | In distribution |
| RT047XS | EXTRA SMALL | In distribution |
| 900PT572US | In distribution | |
| 900PT573US | In distribution | |
| RT055S | Small | In distribution |
| PT311US | In distribution | |
| RT045S | Small | In distribution |
| RT043S | SMALL | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BiPAP A40 | Respironics Inc. | 102 |
| Philips | Respironics California, Inc. | 29 |
| DreamMapper | Respironics Inc. | 27 |
| BiPAP | Respironics Inc. | 11 |
| EncoreAnywhere | Respironics Inc. | 10 |
| Care Orchestrator | Respironics Inc. | 8 |
| A Series | Respironics Inc. | 7 |
| Nihon Kohden | Nihon Kohden Orangemed, LLC | 6 |
| Remote Alarm | Resmed PTY Ltd. | 5 |
| Stellar | Resmed PTY Ltd. | 5 |
| AF811 | Respironics Inc. | 4 |
| Battery | Respironics Inc. | 4 |
Showing 12 of 53. All products under Sv70 Ventilator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233643 | 2024-08-09 |
| K191624 | 2020-03-09 |
| K060044 | 2006-04-06 |
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.