Philips
V60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV
4manufacturers in China registered for this device type
29catalogue numbers in this listing
1510(k) clearance
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 | Respironics California, Inc., United States |
|---|---|
| FDA product code | MNT |
| Device type | Sv70 Ventilator |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Record published | 2020-09-22 |
| Record revised | 2020-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 50 °C; Special storage condition: Upright, Fragile, Dry, Do not store more than 2 units on top of the bottom unit.; Handling environment humidity 10 to 95 % RH; Handling environment temperature -20 to 50 °C; Storage environment humidity 10 to 95 % RH; Storage environment atmospheric pressure 60 to 102 KiloPascal |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1055586 | In distribution | |
| 1053613 | In distribution | |
| 1113371 | In distribution | |
| 1076716 | In distribution | |
| 1055568 | In distribution | |
| 1055588 | In distribution | |
| 1109602 | In distribution | |
| 1055571 | In distribution | |
| 1076709 | In distribution | |
| 1076374 | In distribution | |
| 1055584 | In distribution | |
| 1053614 | In distribution | |
| 1109866 | In distribution | |
| 1055581 | In distribution | |
| 1053615 | In distribution | |
| 1055575 | In distribution | |
| 1080588 | In distribution | |
| 1055569 | In distribution | |
| 1055587 | In distribution | |
| 1055585 | In distribution | |
| 1109869 | In distribution | |
| 1055579 | In distribution | |
| 1055578 | In distribution | |
| 1113392 | In distribution | |
| 1055580 | In distribution | |
| 1109881 | In distribution | |
| 1109865 | In distribution | |
| 1055576 | In distribution | |
| 1080782 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BiPAP A40 | Respironics Inc. | 102 |
| DreamMapper | Respironics Inc. | 27 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 25 |
| 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 |
|---|---|
| K082660 | 2009-01-09 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Respironics Inc. | UDI-DI | 2022-02-28 | Class I | Device Design | Ventilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator ceasing to operate. | 87,138 units |
| Respironics Inc. | UDI-DI | 2021-06-18 | Class I | Device Design | It has been identified that ventilators equipped with High Flow Therapy (Software Versions 3.00 and 3.10), that includes a designed safety mechanism that limits the amount of pressure that can be delivered to a patient, in situations where | Total of V60/V60 Plus = 23,115 systems |
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.